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Drug overview for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
Generic name: ACETAMINOPHEN WITH CODEINE PHOSPHATE (a-SEET-a-MIN-oh-fen/KOE-deen)
Drug class: Non-Opioid Analgesic/Antipyretic, Non-Salicylate
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Acetaminophen is a synthetic nonopiate derivative of p-aminophenol that produces analgesia and antipyresis. Codeine is a phenanthrene-derivative opiate agonist.
Acetaminophen is used extensively in the treatment of mild to moderate pain and fever. Codeine is a mild analgesic used in the relief of mild to moderately severe pain that is not relieved by a nonopiate analgesic. Because of differing mechanisms of action, codeine and aspirin or acetaminophen in combination probably produce additive analgesic effects.
Combinations containing codeine, aspirin, and caffeine are effective but produce no more analgesia than a combination of aspirin and codeine. For further information on the role of opiate analgesics in the management of acute or chronic pain, see Uses: Pain, in the Opiate Agonists General Statement 28:08.08. For use of codeine as an antitussive agent, see 48:08
Generic name: ACETAMINOPHEN WITH CODEINE PHOSPHATE (a-SEET-a-MIN-oh-fen/KOE-deen)
Drug class: Non-Opioid Analgesic/Antipyretic, Non-Salicylate
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Acetaminophen is a synthetic nonopiate derivative of p-aminophenol that produces analgesia and antipyresis. Codeine is a phenanthrene-derivative opiate agonist.
Acetaminophen is used extensively in the treatment of mild to moderate pain and fever. Codeine is a mild analgesic used in the relief of mild to moderately severe pain that is not relieved by a nonopiate analgesic. Because of differing mechanisms of action, codeine and aspirin or acetaminophen in combination probably produce additive analgesic effects.
Combinations containing codeine, aspirin, and caffeine are effective but produce no more analgesia than a combination of aspirin and codeine. For further information on the role of opiate analgesics in the management of acute or chronic pain, see Uses: Pain, in the Opiate Agonists General Statement 28:08.08. For use of codeine as an antitussive agent, see 48:08
DRUG IMAGES
ACETAMINOPHEN-COD #3 TABLET
The following indications for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate) have been approved by the FDA:
Indications:
Pain
Professional Synonyms:
None.
Indications:
Pain
Professional Synonyms:
None.
The following dosing information is available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
Codeine salts should be given at the lowest effective dosage and for the shortest duration of therapy consistent with the treatment goals of the patient. Reduced dosage is indicated in poor-risk patients and in very old patients. If concomitant therapy with other CNS depressants is required, the lowest effective dosages and shortest possible duration of concomitant therapy should be used.
When opiate analgesics are administered in fixed combination with nonopiate analgesics, the opiate dosage may be limited by the nonopiate component. Because commercially available preparations contain codeine and nonopiate analgesics in various fixed ratios and because these nonopiate analgesics also are available in many other prescription and OTC preparations, care should be taken to ensure that therapy is not duplicated and that dosage of the nonopiate drug does not exceed maximum recommended dosages.
The initial dosage must be individualized, taking into account the patient's prior opiate use; concurrent drug therapy; degree of opiate tolerance; medical condition; type and severity of pain; and risk factors for addiction, abuse, and misuse.
For the relief of mild to moderate pain in adults, the usual oral dosage of codeine phosphate or codeine sulfate is 30 mg every 4 hours as necessary; the usual dose range is 15-60 mg. Adult dosage should not exceed 360 mg daily.
Children may receive 3 mg/kg or 100 mg/m2 daily in 6 divided doses. Alternatively, children may be given 0.5 mg/kg or 15 mg/m2 every 4-6 hours.
(See Cautions: Pediatric Precautions.)
For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opiate analgesia (generally 3 days or less and rarely more than 7 days). When opiate analgesics are used for the management of chronic noncancer pain, the US Centers for Disease Control and Prevention (CDC) recommends that primary care clinicians carefully reassess individual benefits and risks before prescribing dosages equivalent to 50 mg or more of morphine sulfate daily (approximately 330 mg or more of codeine phosphate or codeine sulfate daily) and avoid dosages equivalent to 90 mg or more of morphine sulfate daily or carefully justify their decision to titrate the dosage to such levels. Other experts recommend consulting a pain management specialist before exceeding a dosage equivalent to 80-120 mg of morphine sulfate daily.
For further information on the management of opiate analgesic therapy, see Dosage and Administration: Dosage, in the Opiate Agonists General Statement 28:08.08.
Acetaminophen is relatively safe when used at recommended dosages. However, acetaminophen overdosage has been the leading cause of acute liver failure in the US, United Kingdom, and most of Europe, with about 50% of US cases in recent years resulting from inadvertent overdosage (e.g., in patients not recognizing the presence of the drug in multiple over-the-counter (OTC) and/or prescription products that they may be taking). Therefore, patients should be warned about the importance of determining whether acetaminophen is present in their medications (e.g., by examining labels carefully, by consulting their clinician and pharmacist) and of not exceeding recommended dosages or combining acetaminophen-containing preparations.
Acetaminophen should not be used for self-medication of pain for longer than 10 days (in adults or children 12 years of age and older) or 5 days (in children 2-11 years of age), unless directed by a clinician because pain of such intensity and duration may indicate a pathologic condition requiring medical evaluation and supervised treatment.
Acetaminophen should not be used in adults or children for self-medication of marked fever (greater than 39.5degreesC), fever persisting longer than 3 days, or recurrent fever, unless directed by a clinician because such fevers may indicate serious illness requiring prompt medical evaluation.
Acetaminophen should not be used in adults or children for self-medication of sore throat pain (pharyngitis, laryngitis, tonsillitis) for longer than 2 days.
To minimize the risk of overdosage, recommended age-appropriate daily dosages of acetaminophen should not be exceeded. Because severe liver toxicity and death have occurred in children who received multiple excessive doses of acetaminophen as part of therapeutic administration, parents or caregivers should be instructed to use weight-based dosing for acetaminophen, to use only the calibrated measuring device provided with the particular acetaminophen formulation for measuring dosage, to ensure that the correct number of tablets required for the intended dose is removed from the package, and not to exceed the recommended daily dosage because serious adverse effects could result. In addition, patients should be warned that the risk of overdosage and severe liver damage is increased if more than one preparation containing acetaminophen are used concomitantly.
Pharmacists have an important role in preventing acetaminophen-induced hepatotoxicity by advising consumers about the risk of failing to recognize that a wide variety of OTC and prescription preparations contain acetaminophen. Failure to recognize acetaminophen as an ingredient may be particularly likely with prescription drugs because the label of the dispensed drug may not clearly state its presence. Educating consumers about the risk of exceeding recommended acetaminophen dosages also is important.
The US Food and Drug Administration (FDA) recommends that pharmacists receiving prescriptions for fixed-combination preparations containing more than 325 mg of acetaminophen per dosage unit contact the prescriber to discuss use of a preparation containing no more than 325 mg of the drug per dosage unit. (See Preparations.)
Clinicians should exercise caution when prescribing, preparing, and administering IV acetaminophen to avoid dosing errors that could result in accidental overdosage and death. In particular, clinicians should ensure that the dose (in mg) and the volume (in mL) are not confused, the dose for patients weighing less than 50 kg is based on body weight, the infusion pump is programmed correctly, and the total daily dosage of acetaminophen from all sources does not exceed the maximum recommended daily dosage.
In patients with hepatic impairment or active liver disease, reduction of the total daily dosage of acetaminophen may be warranted. In patients with severe renal impairment (creatinine clearance of 30 mL/minute or less), longer dosing intervals and a reduced total daily dosage of acetaminophen may be warranted. (See Cautions: Precautions and Contraindications.)
When opiate analgesics are administered in fixed combination with nonopiate analgesics, the opiate dosage may be limited by the nonopiate component. Because commercially available preparations contain codeine and nonopiate analgesics in various fixed ratios and because these nonopiate analgesics also are available in many other prescription and OTC preparations, care should be taken to ensure that therapy is not duplicated and that dosage of the nonopiate drug does not exceed maximum recommended dosages.
The initial dosage must be individualized, taking into account the patient's prior opiate use; concurrent drug therapy; degree of opiate tolerance; medical condition; type and severity of pain; and risk factors for addiction, abuse, and misuse.
For the relief of mild to moderate pain in adults, the usual oral dosage of codeine phosphate or codeine sulfate is 30 mg every 4 hours as necessary; the usual dose range is 15-60 mg. Adult dosage should not exceed 360 mg daily.
Children may receive 3 mg/kg or 100 mg/m2 daily in 6 divided doses. Alternatively, children may be given 0.5 mg/kg or 15 mg/m2 every 4-6 hours.
(See Cautions: Pediatric Precautions.)
For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opiate analgesia (generally 3 days or less and rarely more than 7 days). When opiate analgesics are used for the management of chronic noncancer pain, the US Centers for Disease Control and Prevention (CDC) recommends that primary care clinicians carefully reassess individual benefits and risks before prescribing dosages equivalent to 50 mg or more of morphine sulfate daily (approximately 330 mg or more of codeine phosphate or codeine sulfate daily) and avoid dosages equivalent to 90 mg or more of morphine sulfate daily or carefully justify their decision to titrate the dosage to such levels. Other experts recommend consulting a pain management specialist before exceeding a dosage equivalent to 80-120 mg of morphine sulfate daily.
For further information on the management of opiate analgesic therapy, see Dosage and Administration: Dosage, in the Opiate Agonists General Statement 28:08.08.
Acetaminophen is relatively safe when used at recommended dosages. However, acetaminophen overdosage has been the leading cause of acute liver failure in the US, United Kingdom, and most of Europe, with about 50% of US cases in recent years resulting from inadvertent overdosage (e.g., in patients not recognizing the presence of the drug in multiple over-the-counter (OTC) and/or prescription products that they may be taking). Therefore, patients should be warned about the importance of determining whether acetaminophen is present in their medications (e.g., by examining labels carefully, by consulting their clinician and pharmacist) and of not exceeding recommended dosages or combining acetaminophen-containing preparations.
Acetaminophen should not be used for self-medication of pain for longer than 10 days (in adults or children 12 years of age and older) or 5 days (in children 2-11 years of age), unless directed by a clinician because pain of such intensity and duration may indicate a pathologic condition requiring medical evaluation and supervised treatment.
Acetaminophen should not be used in adults or children for self-medication of marked fever (greater than 39.5degreesC), fever persisting longer than 3 days, or recurrent fever, unless directed by a clinician because such fevers may indicate serious illness requiring prompt medical evaluation.
Acetaminophen should not be used in adults or children for self-medication of sore throat pain (pharyngitis, laryngitis, tonsillitis) for longer than 2 days.
To minimize the risk of overdosage, recommended age-appropriate daily dosages of acetaminophen should not be exceeded. Because severe liver toxicity and death have occurred in children who received multiple excessive doses of acetaminophen as part of therapeutic administration, parents or caregivers should be instructed to use weight-based dosing for acetaminophen, to use only the calibrated measuring device provided with the particular acetaminophen formulation for measuring dosage, to ensure that the correct number of tablets required for the intended dose is removed from the package, and not to exceed the recommended daily dosage because serious adverse effects could result. In addition, patients should be warned that the risk of overdosage and severe liver damage is increased if more than one preparation containing acetaminophen are used concomitantly.
Pharmacists have an important role in preventing acetaminophen-induced hepatotoxicity by advising consumers about the risk of failing to recognize that a wide variety of OTC and prescription preparations contain acetaminophen. Failure to recognize acetaminophen as an ingredient may be particularly likely with prescription drugs because the label of the dispensed drug may not clearly state its presence. Educating consumers about the risk of exceeding recommended acetaminophen dosages also is important.
The US Food and Drug Administration (FDA) recommends that pharmacists receiving prescriptions for fixed-combination preparations containing more than 325 mg of acetaminophen per dosage unit contact the prescriber to discuss use of a preparation containing no more than 325 mg of the drug per dosage unit. (See Preparations.)
Clinicians should exercise caution when prescribing, preparing, and administering IV acetaminophen to avoid dosing errors that could result in accidental overdosage and death. In particular, clinicians should ensure that the dose (in mg) and the volume (in mL) are not confused, the dose for patients weighing less than 50 kg is based on body weight, the infusion pump is programmed correctly, and the total daily dosage of acetaminophen from all sources does not exceed the maximum recommended daily dosage.
In patients with hepatic impairment or active liver disease, reduction of the total daily dosage of acetaminophen may be warranted. In patients with severe renal impairment (creatinine clearance of 30 mL/minute or less), longer dosing intervals and a reduced total daily dosage of acetaminophen may be warranted. (See Cautions: Precautions and Contraindications.)
Codeine sulfate and codeine phosphate are administered orally. Acetaminophen is administered orally, rectally as suppositories, and by IV infusion over 15 minutes. Acetaminophen preparations for self-medication should not be used unless seals on the tamper-resistant packaging are intact.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACETAMINOPHEN-COD #3 TABLET | Maintenance | Adults take 1 tablet by oral route every 6 hours as needed |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACETAMINOPHEN-COD #3 TABLET | Maintenance | Adults take 1 tablet by oral route every 6 hours as needed |
The following drug interaction information is available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 6 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Acetaminophen overdose |
| Acute asthma attack |
| Acute hepatic failure |
| Acute hepatitis C |
| Adenoidectomy in pediatric patient |
| Tonsillectomy in pediatric patient |
There are 17 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute pancreatitis |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| CYp2d6 poor metabolizer |
| CYp2d6 ultrarapid metabolizer |
| Disease of liver |
| Drug abuse |
| Exacerbation of chronic obstructive pulmonary disease |
| Familial dysautonomia |
| Gastrointestinal obstruction |
| History of opioid overdose |
| Intracranial hypertension |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| Protein-calorie malnutrition |
| Respiratory depression |
| Shock |
| Sleep apnea |
| Systemic mastocytosis |
There are 11 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Adrenocortical insufficiency |
| Alcohol intoxication |
| Biliary tract disorder |
| Constipation |
| Cor pulmonale |
| Debilitation |
| Hypotension |
| Seizure disorder |
| Severe hepatic disease |
| Untreated hypothyroidism |
| Urinary retention |
The following adverse reaction information is available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 34 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abnormal hepatic function tests Atelectasis CNS depression Dyspnea Hypotension Orthostatic hypotension Respiratory depression |
| Rare/Very Rare |
|---|
|
Accidental fall Acute generalized exanthematous pustulosis Acute hepatic failure Acute respiratory failure Adrenocortical insufficiency Agranulocytosis Allergic dermatitis Anaphylaxis Androgen deficiency Angioedema Bradycardia Cardiac arrest Drug dependence Drug-induced hepatitis Ileus Laryngeal edema Leukopenia Maculopapular rash Neutropenic disorder Opioid dependence Pancreatitis Seizure disorder Shock Sleep apnea Stevens-johnson syndrome Thrombocytopenic disorder Toxic epidermal necrolysis |
There are 42 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal pain with cramps Constipation Drowsy Hyperhidrosis Nausea Sedation Vomiting |
Acute cognitive impairment Anorexia Dizziness Dysphoric mood General weakness Headache disorder Nervousness Oliguria Palpitations Pruritus of skin Skin rash Syncope Urticaria Visual changes Xerostomia |
| Rare/Very Rare |
|---|
|
Biliary spasm Depression Diarrhea Erectile dysfunction Erythema Euphoria Fatigue Flushing Gastrointestinal irritation Infertility Insomnia Libido changes Medication overuse headache Opioid induced allodynia Opioid induced hyperalgesia Skin rash Symptoms of anxiety Urticaria Vasodilation of blood vessels Vertigo |
The following precautions are available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Epidemiologic data regarding oral acetaminophen use in pregnant women have shown no increased risk of major congenital malformations in infants exposed in utero to the drug. In a large population-based prospective cohort study involving more than 26,000 women with live-born singleton infants who were exposed to oral acetaminophen during the first trimester of pregnancy, no increase in the risk of congenital malformations was observed in exposed children compared with a control group of unexposed children; the rate of congenital malformations (4.3%) was similar to the rate in the general population. A population-based, case-control study from the National Birth Defects Prevention Study also found no increase in the risk of major birth defects in a group of 11,610 children who had been exposed to acetaminophen during the first trimester of pregnancy compared with a control group of 4500 children.
Animal reproduction studies in pregnant rats given oral acetaminophen during organogenesis at dosages up to 0.85 times the maximum recommended human daily dosage (4 g daily, based on body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes); the offspring showed no evidence of external, visceral, or skeletal malformations. When pregnant rats received oral acetaminophen throughout gestation at a dosage of 1.2
times the maximum recommended human daily dosage, areas of necrosis occurred in both the liver and kidney of pregnant rats and fetuses; these effects did not occur in animals given acetaminophen at dosages of 0.3 times the maximum recommended human dosage. In a continuous breeding study in which pregnant mice were given acetaminophen at dosages approximately equivalent to 0.43,
0.87, or 1.7 times the maximum recommended human daily dosage (based on body surface area comparison), a dose-related reduction in body weight of the fourth and fifth litter offspring of the treated mating pair occurred during lactation and following weaning at all dosages studied.
Animals receiving the highest dosage had a reduced number of litters per mating pair, male offspring with an increased percentage of abnormal sperm, and reduced birth weights in the next-generation pups. Acetaminophen is commonly used during all stages of pregnancy for its analgesic and antipyretic effects. Although acetaminophen has been thought not to be associated with risk in offspring, some recent reports have questioned this assessment, especially with frequent maternal use or in cases involving genetic variability.
FDA reviewed data on a possible association between acetaminophen use during pregnancy and risk of attention deficit hyperactivity disorder (ADHD) in children and announced in January 2015 that the data were inconclusive. Some experts state that as with all drug use during pregnancy, routine use of acetaminophen should be avoided. The manufacturer states that there are no studies of IV acetaminophen in pregnant women and animal reproduction studies have not been conducted with this preparation.
Therefore, the manufacturer states that IV acetaminophen should be used during pregnancy only when clearly needed. Because there are no adequate and well-controlled studies of IV acetaminophen during labor and delivery, the manufacturer states that IV acetaminophen should be used in this setting only after careful assessment of potential benefits and risks.
Animal reproduction studies in pregnant rats given oral acetaminophen during organogenesis at dosages up to 0.85 times the maximum recommended human daily dosage (4 g daily, based on body surface area comparison) showed evidence of fetotoxicity (reduced fetal weight and length) and a dose-related increase in bone variations (reduced ossification and rudimentary rib changes); the offspring showed no evidence of external, visceral, or skeletal malformations. When pregnant rats received oral acetaminophen throughout gestation at a dosage of 1.2
times the maximum recommended human daily dosage, areas of necrosis occurred in both the liver and kidney of pregnant rats and fetuses; these effects did not occur in animals given acetaminophen at dosages of 0.3 times the maximum recommended human dosage. In a continuous breeding study in which pregnant mice were given acetaminophen at dosages approximately equivalent to 0.43,
0.87, or 1.7 times the maximum recommended human daily dosage (based on body surface area comparison), a dose-related reduction in body weight of the fourth and fifth litter offspring of the treated mating pair occurred during lactation and following weaning at all dosages studied.
Animals receiving the highest dosage had a reduced number of litters per mating pair, male offspring with an increased percentage of abnormal sperm, and reduced birth weights in the next-generation pups. Acetaminophen is commonly used during all stages of pregnancy for its analgesic and antipyretic effects. Although acetaminophen has been thought not to be associated with risk in offspring, some recent reports have questioned this assessment, especially with frequent maternal use or in cases involving genetic variability.
FDA reviewed data on a possible association between acetaminophen use during pregnancy and risk of attention deficit hyperactivity disorder (ADHD) in children and announced in January 2015 that the data were inconclusive. Some experts state that as with all drug use during pregnancy, routine use of acetaminophen should be avoided. The manufacturer states that there are no studies of IV acetaminophen in pregnant women and animal reproduction studies have not been conducted with this preparation.
Therefore, the manufacturer states that IV acetaminophen should be used during pregnancy only when clearly needed. Because there are no adequate and well-controlled studies of IV acetaminophen during labor and delivery, the manufacturer states that IV acetaminophen should be used in this setting only after careful assessment of potential benefits and risks.
Acetaminophen is distributed into human milk in small quantities after oral administration. Data from more than 15 nursing women suggest that approximately 1-2% of the maternal daily dosage would be ingested by a nursing infant. A case of maculopapular rash in a breast-fed infant has been reported; the rash resolved when the mother discontinued acetaminophen use and recurred when she resumed acetaminophen therapy.
The American Academy of Pediatrics and other experts state that acetaminophen is an acceptable choice for use in nursing women. The manufacturer states that IV acetaminophen should be used with caution in nursing women.
The American Academy of Pediatrics and other experts state that acetaminophen is an acceptable choice for use in nursing women. The manufacturer states that IV acetaminophen should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate):
WARNING: Codeine has a risk for abuse and addiction, which can lead to overdose and death. Codeine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of codeine that works, and take it for the shortest possible time.
See also How to Use section for more information about addiction. Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.
The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of codeine from your body, which may affect how codeine works.
Be sure you know how to take this medication and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away. One ingredient in this product is acetaminophen.
Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen.
Ask your doctor or pharmacist how much acetaminophen is safe to take. Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products).
Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits.
Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy.
Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms.
Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight. Children younger than 18 years should not use products that contain codeine. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section).
The risk is greater in children who are obese or have breathing problems, or after certain surgeries (including tonsil/adenoid removal). Talk with your doctor or pharmacist about the risks and benefits of this medication.
WARNING: Codeine has a risk for abuse and addiction, which can lead to overdose and death. Codeine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of codeine that works, and take it for the shortest possible time.
See also How to Use section for more information about addiction. Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.
The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of codeine from your body, which may affect how codeine works.
Be sure you know how to take this medication and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away. One ingredient in this product is acetaminophen.
Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen.
Ask your doctor or pharmacist how much acetaminophen is safe to take. Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products).
Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits.
Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy.
Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms.
Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight. Children younger than 18 years should not use products that contain codeine. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section).
The risk is greater in children who are obese or have breathing problems, or after certain surgeries (including tonsil/adenoid removal). Talk with your doctor or pharmacist about the risks and benefits of this medication.
The following icd codes are available for ACETAMINOPHEN-CODEINE (acetaminophen with codeine phosphate)'s list of indications:
| Pain | |
| G43 | Migraine |
| G43.0 | Migraine without aura |
| G43.00 | Migraine without aura, not intractable |
| G43.001 | Migraine without aura, not intractable, with status migrainosus |
| G43.009 | Migraine without aura, not intractable, without status migrainosus |
| G43.01 | Migraine without aura, intractable |
| G43.011 | Migraine without aura, intractable, with status migrainosus |
| G43.019 | Migraine without aura, intractable, without status migrainosus |
| G43.1 | Migraine with aura |
| G43.10 | Migraine with aura, not intractable |
| G43.101 | Migraine with aura, not intractable, with status migrainosus |
| G43.109 | Migraine with aura, not intractable, without status migrainosus |
| G43.11 | Migraine with aura, intractable |
| G43.111 | Migraine with aura, intractable, with status migrainosus |
| G43.119 | Migraine with aura, intractable, without status migrainosus |
| G43.4 | Hemiplegic migraine |
| G43.40 | Hemiplegic migraine, not intractable |
| G43.401 | Hemiplegic migraine, not intractable, with status migrainosus |
| G43.409 | Hemiplegic migraine, not intractable, without status migrainosus |
| G43.41 | Hemiplegic migraine, intractable |
| G43.411 | Hemiplegic migraine, intractable, with status migrainosus |
| G43.419 | Hemiplegic migraine, intractable, without status migrainosus |
| G43.5 | Persistent migraine aura without cerebral infarction |
| G43.50 | Persistent migraine aura without cerebral infarction, not intractable |
| G43.501 | Persistent migraine aura without cerebral infarction, not intractable, with status migrainosus |
| G43.509 | Persistent migraine aura without cerebral infarction, not intractable, without status migrainosus |
| G43.51 | Persistent migraine aura without cerebral infarction, intractable |
| G43.511 | Persistent migraine aura without cerebral infarction, intractable, with status migrainosus |
| G43.519 | Persistent migraine aura without cerebral infarction, intractable, without status migrainosus |
| G43.6 | Persistent migraine aura with cerebral infarction |
| G43.60 | Persistent migraine aura with cerebral infarction, not intractable |
| G43.601 | Persistent migraine aura with cerebral infarction, not intractable, with status migrainosus |
| G43.609 | Persistent migraine aura with cerebral infarction, not intractable, without status migrainosus |
| G43.61 | Persistent migraine aura with cerebral infarction, intractable |
| G43.611 | Persistent migraine aura with cerebral infarction, intractable, with status migrainosus |
| G43.619 | Persistent migraine aura with cerebral infarction, intractable, without status migrainosus |
| G43.7 | Chronic migraine without aura |
| G43.70 | Chronic migraine without aura, not intractable |
| G43.701 | Chronic migraine without aura, not intractable, with status migrainosus |
| G43.709 | Chronic migraine without aura, not intractable, without status migrainosus |
| G43.71 | Chronic migraine without aura, intractable |
| G43.711 | Chronic migraine without aura, intractable, with status migrainosus |
| G43.719 | Chronic migraine without aura, intractable, without status migrainosus |
| G43.8 | Other migraine |
| G43.80 | Other migraine, not intractable |
| G43.801 | Other migraine, not intractable, with status migrainosus |
| G43.809 | Other migraine, not intractable, without status migrainosus |
| G43.81 | Other migraine, intractable |
| G43.811 | Other migraine, intractable, with status migrainosus |
| G43.819 | Other migraine, intractable, without status migrainosus |
| G43.82 | Menstrual migraine, not intractable |
| G43.821 | Menstrual migraine, not intractable, with status migrainosus |
| G43.829 | Menstrual migraine, not intractable, without status migrainosus |
| G43.83 | Menstrual migraine, intractable |
| G43.831 | Menstrual migraine, intractable, with status migrainosus |
| G43.839 | Menstrual migraine, intractable, without status migrainosus |
| G43.9 | Migraine, unspecified |
| G43.90 | Migraine, unspecified, not intractable |
| G43.901 | Migraine, unspecified, not intractable, with status migrainosus |
| G43.909 | Migraine, unspecified, not intractable, without status migrainosus |
| G43.91 | Migraine, unspecified, intractable |
| G43.911 | Migraine, unspecified, intractable, with status migrainosus |
| G43.919 | Migraine, unspecified, intractable, without status migrainosus |
| G43.B | Ophthalmoplegic migraine |
| G43.B0 | Ophthalmoplegic migraine, not intractable |
| G43.B1 | Ophthalmoplegic migraine, intractable |
| G43.C | Periodic headache syndromes in child or adult |
| G43.C0 | Periodic headache syndromes in child or adult, not intractable |
| G43.C1 | Periodic headache syndromes in child or adult, intractable |
| G43.D | Abdominal migraine |
| G43.D0 | Abdominal migraine, not intractable |
| G43.D1 | Abdominal migraine, intractable |
| G43.E | Chronic migraine with aura |
| G43.E0 | Chronic migraine with aura, not intractable |
| G43.E01 | Chronic migraine with aura, not intractable, with status migrainosus |
| G43.E09 | Chronic migraine with aura, not intractable, without status migrainosus |
| G43.E1 | Chronic migraine with aura, intractable |
| G43.E11 | Chronic migraine with aura, intractable, with status migrainosus |
| G43.E19 | Chronic migraine with aura, intractable, without status migrainosus |
| G44 | Other headache syndromes |
| G44.00 | Cluster headache syndrome, unspecified |
| G44.001 | Cluster headache syndrome, unspecified, intractable |
| G44.009 | Cluster headache syndrome, unspecified, not intractable |
| G44.01 | Episodic cluster headache |
| G44.011 | Episodic cluster headache, intractable |
| G44.019 | Episodic cluster headache, not intractable |
| G44.02 | Chronic cluster headache |
| G44.021 | Chronic cluster headache, intractable |
| G44.029 | Chronic cluster headache, not intractable |
| G44.03 | Episodic paroxysmal hemicrania |
| G44.031 | Episodic paroxysmal hemicrania, intractable |
| G44.039 | Episodic paroxysmal hemicrania, not intractable |
| G44.04 | Chronic paroxysmal hemicrania |
| G44.041 | Chronic paroxysmal hemicrania, intractable |
| G44.049 | Chronic paroxysmal hemicrania, not intractable |
| G44.05 | Short lasting unilateral neuralgiform headache with conjunctival injection and tearing (SUNCt) |
| G44.051 | Short lasting unilateral neuralgiform headache with conjunctival injection and tearing (SUNCt), intractable |
| G44.059 | Short lasting unilateral neuralgiform headache with conjunctival injection and tearing (SUNCt), not intractable |
| G44.1 | Vascular headache, not elsewhere classified |
| G44.2 | Tension-type headache |
| G44.20 | Tension-type headache, unspecified |
| G44.201 | Tension-type headache, unspecified, intractable |
| G44.209 | Tension-type headache, unspecified, not intractable |
| G44.21 | Episodic tension-type headache |
| G44.211 | Episodic tension-type headache, intractable |
| G44.219 | Episodic tension-type headache, not intractable |
| G44.22 | Chronic tension-type headache |
| G44.221 | Chronic tension-type headache, intractable |
| G44.229 | Chronic tension-type headache, not intractable |
| G44.3 | Post-traumatic headache |
| G44.30 | Post-traumatic headache, unspecified |
| G44.301 | Post-traumatic headache, unspecified, intractable |
| G44.309 | Post-traumatic headache, unspecified, not intractable |
| G44.31 | Acute post-traumatic headache |
| G44.311 | Acute post-traumatic headache, intractable |
| G44.319 | Acute post-traumatic headache, not intractable |
| G44.32 | Chronic post-traumatic headache |
| G44.321 | Chronic post-traumatic headache, intractable |
| G44.329 | Chronic post-traumatic headache, not intractable |
| G44.4 | Drug-induced headache, not elsewhere classified |
| G44.40 | Drug-induced headache, not elsewhere classified, not intractable |
| G44.41 | Drug-induced headache, not elsewhere classified, intractable |
| G44.5 | Complicated headache syndromes |
| G44.51 | Hemicrania continua |
| G44.52 | New daily persistent headache (NDPh) |
| G44.53 | Primary thunderclap headache |
| G44.59 | Other complicated headache syndrome |
| G44.8 | Other specified headache syndromes |
| G44.81 | Hypnic headache |
| G44.82 | Headache associated with sexual activity |
| G44.83 | Primary cough headache |
| G44.84 | Primary exertional headache |
| G44.85 | Primary stabbing headache |
| G44.86 | Cervicogenic headache |
| G44.89 | Other headache syndrome |
| G50.1 | Atypical facial pain |
| G89 | Pain, not elsewhere classified |
| G89.0 | Central pain syndrome |
| G89.1 | Acute pain, not elsewhere classified |
| G89.11 | Acute pain due to trauma |
| G89.12 | Acute post-thoracotomy pain |
| G89.18 | Other acute postprocedural pain |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.21 | Chronic pain due to trauma |
| G89.22 | Chronic post-thoracotomy pain |
| G89.28 | Other chronic postprocedural pain |
| G89.29 | Other chronic pain |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| G89.4 | Chronic pain syndrome |
| G90.5 | Complex regional pain syndrome I (CRPS i) |
| G90.50 | Complex regional pain syndrome i, unspecified |
| G90.51 | Complex regional pain syndrome I of upper limb |
| G90.511 | Complex regional pain syndrome I of right upper limb |
| G90.512 | Complex regional pain syndrome I of left upper limb |
| G90.513 | Complex regional pain syndrome I of upper limb, bilateral |
| G90.519 | Complex regional pain syndrome I of unspecified upper limb |
| G90.52 | Complex regional pain syndrome I of lower limb |
| G90.521 | Complex regional pain syndrome I of right lower limb |
| G90.522 | Complex regional pain syndrome I of left lower limb |
| G90.523 | Complex regional pain syndrome I of lower limb, bilateral |
| G90.529 | Complex regional pain syndrome I of unspecified lower limb |
| G90.59 | Complex regional pain syndrome I of other specified site |
| H57.1 | Ocular pain |
| H57.10 | Ocular pain, unspecified eye |
| H57.11 | Ocular pain, right eye |
| H57.12 | Ocular pain, left eye |
| H57.13 | Ocular pain, bilateral |
| H92 | Otalgia and effusion of ear |
| H92.0 | Otalgia |
| H92.01 | Otalgia, right ear |
| H92.02 | Otalgia, left ear |
| H92.03 | Otalgia, bilateral |
| H92.09 | Otalgia, unspecified ear |
| K14.6 | Glossodynia |
| M25.5 | Pain in joint |
| M25.50 | Pain in unspecified joint |
| M25.51 | Pain in shoulder |
| M25.511 | Pain in right shoulder |
| M25.512 | Pain in left shoulder |
| M25.519 | Pain in unspecified shoulder |
| M25.52 | Pain in elbow |
| M25.521 | Pain in right elbow |
| M25.522 | Pain in left elbow |
| M25.529 | Pain in unspecified elbow |
| M25.53 | Pain in wrist |
| M25.531 | Pain in right wrist |
| M25.532 | Pain in left wrist |
| M25.539 | Pain in unspecified wrist |
| M25.54 | Pain in joints of hand |
| M25.541 | Pain in joints of right hand |
| M25.542 | Pain in joints of left hand |
| M25.549 | Pain in joints of unspecified hand |
| M25.55 | Pain in hip |
| M25.551 | Pain in right hip |
| M25.552 | Pain in left hip |
| M25.559 | Pain in unspecified hip |
| M25.56 | Pain in knee |
| M25.561 | Pain in right knee |
| M25.562 | Pain in left knee |
| M25.569 | Pain in unspecified knee |
| M25.57 | Pain in ankle and joints of foot |
| M25.571 | Pain in right ankle and joints of right foot |
| M25.572 | Pain in left ankle and joints of left foot |
| M25.579 | Pain in unspecified ankle and joints of unspecified foot |
| M25.59 | Pain in other specified joint |
| M26.62 | Arthralgia of temporomandibular joint |
| M26.621 | Arthralgia of right temporomandibular joint |
| M26.622 | Arthralgia of left temporomandibular joint |
| M26.623 | Arthralgia of bilateral temporomandibular joint |
| M26.629 | Arthralgia of temporomandibular joint, unspecified side |
| M54 | Dorsalgia |
| M54.2 | Cervicalgia |
| M54.4 | Lumbago with sciatica |
| M54.40 | Lumbago with sciatica, unspecified side |
| M54.41 | Lumbago with sciatica, right side |
| M54.42 | Lumbago with sciatica, left side |
| M54.5 | Low back pain |
| M54.50 | Low back pain, unspecified |
| M54.51 | Vertebrogenic low back pain |
| M54.59 | Other low back pain |
| M54.6 | Pain in thoracic spine |
| M54.8 | Other dorsalgia |
| M54.89 | Other dorsalgia |
| M54.9 | Dorsalgia, unspecified |
| M77.4 | Metatarsalgia |
| M77.40 | Metatarsalgia, unspecified foot |
| M77.41 | Metatarsalgia, right foot |
| M77.42 | Metatarsalgia, left foot |
| M79.1 | Myalgia |
| M79.10 | Myalgia, unspecified site |
| M79.11 | Myalgia of mastication muscle |
| M79.12 | Myalgia of auxiliary muscles, head and neck |
| M79.18 | Myalgia, other site |
| M79.6 | Pain in limb, hand, foot, fingers and toes |
| M79.60 | Pain in limb, unspecified |
| M79.601 | Pain in right arm |
| M79.602 | Pain in left arm |
| M79.603 | Pain in arm, unspecified |
| M79.604 | Pain in right leg |
| M79.605 | Pain in left leg |
| M79.606 | Pain in leg, unspecified |
| M79.609 | Pain in unspecified limb |
| M79.62 | Pain in upper arm |
| M79.621 | Pain in right upper arm |
| M79.622 | Pain in left upper arm |
| M79.629 | Pain in unspecified upper arm |
| M79.63 | Pain in forearm |
| M79.631 | Pain in right forearm |
| M79.632 | Pain in left forearm |
| M79.639 | Pain in unspecified forearm |
| M79.64 | Pain in hand and fingers |
| M79.641 | Pain in right hand |
| M79.642 | Pain in left hand |
| M79.643 | Pain in unspecified hand |
| M79.644 | Pain in right finger(s) |
| M79.645 | Pain in left finger(s) |
| M79.646 | Pain in unspecified finger(s) |
| M79.65 | Pain in thigh |
| M79.651 | Pain in right thigh |
| M79.652 | Pain in left thigh |
| M79.659 | Pain in unspecified thigh |
| M79.66 | Pain in lower leg |
| M79.661 | Pain in right lower leg |
| M79.662 | Pain in left lower leg |
| M79.669 | Pain in unspecified lower leg |
| M79.67 | Pain in foot and toes |
| M79.671 | Pain in right foot |
| M79.672 | Pain in left foot |
| M79.673 | Pain in unspecified foot |
| M79.674 | Pain in right toe(s) |
| M79.675 | Pain in left toe(s) |
| M79.676 | Pain in unspecified toe(s) |
| N23 | Unspecified renal colic |
| N64.4 | Mastodynia |
| N94 | Pain and other conditions associated with female genital organs and menstrual cycle |
| N94.0 | Mittelschmerz |
| N94.3 | Premenstrual tension syndrome |
| N94.4 | Primary dysmenorrhea |
| N94.5 | Secondary dysmenorrhea |
| N94.6 | Dysmenorrhea, unspecified |
| R07 | Pain in throat and chest |
| R07.0 | Pain in throat |
| R07.1 | Chest pain on breathing |
| R07.2 | Precordial pain |
| R07.81 | Pleurodynia |
| R07.82 | Intercostal pain |
| R07.89 | Other chest pain |
| R07.9 | Chest pain, unspecified |
| R10 | Abdominal and pelvic pain |
| R10.0 | Acute abdomen |
| R10.1 | Pain localized to upper abdomen |
| R10.10 | Upper abdominal pain, unspecified |
| R10.11 | Right upper quadrant pain |
| R10.12 | Left upper quadrant pain |
| R10.2 | Pelvic and perineal pain |
| R10.3 | Pain localized to other parts of lower abdomen |
| R10.30 | Lower abdominal pain, unspecified |
| R10.31 | Right lower quadrant pain |
| R10.32 | Left lower quadrant pain |
| R10.33 | Periumbilical pain |
| R10.8 | Other abdominal pain |
| R10.83 | Colic |
| R10.84 | Generalized abdominal pain |
| R10.9 | Unspecified abdominal pain |
| R51 | Headache |
| R51.0 | Headache with orthostatic component, not elsewhere classified |
| R51.9 | Headache, unspecified |
| R52 | Pain, unspecified |
| R68.84 | Jaw pain |
| T82.84 | Pain due to cardiac and vascular prosthetic devices, implants and grafts |
| T82.847 | Pain due to cardiac prosthetic devices, implants and grafts |
| T82.847A | Pain due to cardiac prosthetic devices, implants and grafts, initial encounter |
| T82.847D | Pain due to cardiac prosthetic devices, implants and grafts, subsequent encounter |
| T82.848 | Pain due to vascular prosthetic devices, implants and grafts |
| T82.848A | Pain due to vascular prosthetic devices, implants and grafts, initial encounter |
| T82.848D | Pain due to vascular prosthetic devices, implants and grafts, subsequent encounter |
| T83.84 | Pain due to genitourinary prosthetic devices, implants and grafts |
| T83.84xA | Pain due to genitourinary prosthetic devices, implants and grafts, initial encounter |
| T83.84xD | Pain due to genitourinary prosthetic devices, implants and grafts, subsequent encounter |
| T84.84 | Pain due to internal orthopedic prosthetic devices, implants and grafts |
| T84.84xA | Pain due to internal orthopedic prosthetic devices, implants and grafts, initial encounter |
| T84.84xD | Pain due to internal orthopedic prosthetic devices, implants and grafts, subsequent encounter |
| T85.84 | Pain due to internal prosthetic devices, implants and grafts, not elsewhere classified |
| T85.840 | Pain due to nervous system prosthetic devices, implants and grafts |
| T85.840A | Pain due to nervous system prosthetic devices, implants and grafts, initial encounter |
| T85.840D | Pain due to nervous system prosthetic devices, implants and grafts, subsequent encounter |
| T85.848 | Pain due to other internal prosthetic devices, implants and grafts |
| T85.848A | Pain due to other internal prosthetic devices, implants and grafts, initial encounter |
| T85.848D | Pain due to other internal prosthetic devices, implants and grafts, subsequent encounter |
Formulary Reference Tool