Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine Liquid

Name: Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine Liquid

How is this medicine (Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine Liquid) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Measure liquid doses carefully. Use the measuring device that comes with acetaminophen, chlorpheniramine, dextromethorphan, phenylephrine liquid. If there is none, ask the pharmacist for a device to measure this medicine.

What do I do if I miss a dose?

  • If you take acetaminophen, chlorpheniramine, dextromethorphan, phenylephrine liquid on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this medicine is used on an as needed basis. Do not use more often than told by the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

For Healthcare Professionals

Applies to acetaminophen / chlorpheniramine / dextromethorphan / phenylephrine: oral liquid, oral suspension, oral tablet

Cardiovascular

Cardiovascular side effects of acetaminophen have included two cases of hypotension.

Cardiovascular side effects of chlorpheniramine have included hypotension, tachycardia, and palpitations.

Cardiovascular side effects of phenylephrine have included palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Nervous system

Nervous system side effects of chlorpheniramine have included depression resulting in drowsiness in 75% or more of treated patients. Dyskinesias have rarely been reported following chronic use of chlorpheniramine.

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Other side effects such as excitation, mental confusion, and opiate-like respiratory depression have been rare and occurred at higher dosages. In some cases of abuse, patients experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.

Nervous system side effects of phenylephrine have included headache, dizziness, nervousness, restlessness, tremor, insomnia, convulsions, and central nervous system depression.[Ref]

Few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of chlorpheniramine extended over a period of 3 to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Gastrointestinal side effects of acetaminophen have been rare, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

Gastrointestinal side effects of chlorpheniramine have included dry mouth and constipation in up to one-third of treated patients.

Gastrointestinal side effects of dextromethorphan have included stomach upset.

Gastrointestinal side effects of phenylephrine have included nausea.[Ref]

Hypersensitivity

Hypersensitivity side effects of acetaminophen have included anaphylaxis and fixed drug eruptions.

Hypersensitivity side effects of dextromethorphan have included rare reports of fixed-drug eruptions.[Ref]

General

General side effects of phenylephrine have included pallor and weakness.[Ref]

Psychiatric

Psychiatric side effects of phenylephrine have included hallucinations, fear, and anxiety.[Ref]

Genitourinary

Genitourinary side effects of chlorpheniramine have included dysuria, urinary hesitancy, and decreased urine flow.

Genitourinary side effects of phenylephrine have included dysuria.[Ref]

Respiratory

Respiratory side effects of acetaminophen have included a case of eosinophilic pneumonia.

Respiratory side effects of phenylephrine have included respiratory difficulty.[Ref]

Hepatic

Hepatic side effects of acetaminophen have included severe and sometimes fatal dose dependent hepatitis in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Renal

Renal side effects of acetaminophen have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.[Ref]

Hematologic

Hematologic side effects of acetaminophen have included rare cases of thrombocytopenia. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Hematologic side effects of chlorpheniramine have included bone marrow suppression, thrombocytopenia, and aplastic anemia.[Ref]

A fatal case of agranulocytosis has been reported in a patient taking chlorpheniramine, pseudoephedrine, acetaminophen, dextromethorphan, phenylpropanolamine, and aspirin. Chlorpheniramine was felt to be the cause.[Ref]

Dermatologic

Dermatologic side effects of acetaminophen have included erythematous skin rashes. Bullous erythema and purpura fulminans have also been reported.[Ref]

Metabolic

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.[Ref]

Metabolic side effects of acetaminophen have included metabolic acidosis following a massive overdose.[Ref]

Ocular

Ocular side effects of chlorpheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]

Some side effects of acetaminophen / chlorpheniramine / dextromethorphan / phenylephrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Acetaminophen / chlorpheniramine / dextromethorphan / phenylephrine Pregnancy Warnings

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 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. Phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine is only recommended for use during pregnancy when benefits outweighs risk.

Acetaminophen / chlorpheniramine / dextromethorphan / phenylephrine Breastfeeding Warnings

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.

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. Small amounts of phenylephrine are secreted in breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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