Acetaminophen, chlorpheniramine, and dextromethorphan

Name: Acetaminophen, chlorpheniramine, and dextromethorphan

What is the most important information I should know about this medicine?

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Acetaminophen, chlorpheniramine, and dextromethorphan dosing information

Usual Adult Dose for Cold Symptoms:

Acetaminophen/chlorpheniramine/dextromethorphan 500 mg-2 mg-15 mg tablets: 2 tablets orally every 6 hours, while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.

Usual Adult Dose for Influenza:

Acetaminophen/chlorpheniramine/dextromethorphan 500 mg-2 mg-15 mg tablets: 2 tablets orally every 6 hours, while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen/chlorpheniramine/dextromethorphan 160 mg-1 mg-5 mg/5 mL oral suspension:
Greater than or equal to 6 years to less than 12 years: 10 mL orally every 4 hours not to exceed 5 doses daily.

Acetaminophen/chlorpheniramine/dextromethorphan 160 mg-1 mg-7.5 mg/5 mL oral liquid:
Greater than or equal to 6 years to less than 12 years: 10 mL orally every 6 hours not to exceed 4 doses daily.

Acetaminophen/chlorpheniramine/dextromethorphan 500 mg-2 mg-15 mg tablets:
Greater than or equal to 12 years: 2 tablets orally every 6 hours, while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.

Usual Pediatric Dose for Influenza:

Acetaminophen/chlorpheniramine/dextromethorphan 160 mg-1 mg-5 mg/5 mL oral suspension:
Greater than or equal to 6 years to less than 12 years: 10 mL orally every 4 hours not to exceed 5 doses daily.

Acetaminophen/chlorpheniramine/dextromethorphan 160 mg-1 mg-7.5 mg/5 mL oral liquid:
Greater than or equal to 6 years to less than 12 years: 10 mL orally every 6 hours not to exceed 4 doses daily.

Acetaminophen/chlorpheniramine/dextromethorphan 500 mg-2 mg-15 mg tablets:
Greater than or equal to 12 years: 2 tablets orally every 6 hours, while symptoms persist, not to exceed 8 tablets in 24 hours, or as directed by a doctor.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, chlorpheniramine, and dextromethorphan with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dialysis

Data not available

Acetaminophen / chlorpheniramine / dextromethorphan Pregnancy Warnings

Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Chlorpheniramine has been assigned to pregnancy category B by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Dextromethorphan has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Acetaminophen/chlorpheniramine/dextromethorphan is only recommended for use during pregnancy when benefits outweighs risk.

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production. The Collaborative Perinatal Project monitored 1,070 first trimester exposures and 3,931 exposures which occurred anytime during pregnancy. No evidence was found to suggest a relationship to large categories of malformations. Antihistamine exposure in the first trimester in general was not associated with an increased risk of malformations.

Acetaminophen / chlorpheniramine / dextromethorphan Breastfeeding Warnings

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of chlorpheniramine into human milk. There are no data on the excretion of dextromethorphan into human milk. Caution is recommended if acetaminophen/chlorpheniramine/dextromethorphan is to be given to a nursing woman.

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose. Based on the low molecular weight of dextromethorphan some passage into breast milk probably occurs. However, maternal use of dextromethorphan products that do not contain alcohol are probably safe to use during breast-feeding.

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