Acetaminophen, pheniramine, and phenylephrine

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

You should not use this medication if you are allergic to acetaminophen (Tylenol) or chlorpheniramine, or if you have:

• severe constipation, blockage in your stomach or intestines;

• untreated or uncontrolled diseases--glaucoma, asthma or COPD, heart disease, high blood pressure, coronary artery disease, overactive thyroid; or

• if you are unable to urinate.

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

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, pheniramine, and phenylephrine if you have other medical conditions, especially:

• kidney disease;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• an enlarged prostate, problems with urination;

• a history of alcoholism; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether acetaminophen, pheniramine, and phenylephrine will harm an unborn baby. Do not use cold or allergy medicine without a doctor's advice if you are pregnant.

This medicine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use cold or allergy without a doctor's advice if you are breast-feeding a baby.

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Dissolve the contents of one packet of medicine in 8 ounces of hot water. You may also mix the powder with 8 ounces of cool water and heat the mixture in a microwave oven. Stir the mixture thoroughly before and after heating it. Sip the mixture slowly, making sure you finish all of it within 10 to 15 minutes.

Do not take more than 6 packets of this medicine in one day (24 hours).

Call doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no 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. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using the medicine and call your doctor at once if you have:

• chest pain, rapid pulse, fast or uneven heart rate;

• confusion, hallucinations, tremor, severe dizziness or anxiety;

• slow, shallow breathing;

• little or no urinating;

• easy bruising or bleeding, unusual weakness;

• nausea, pain in your upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects may include:

• dryness of the eyes, nose, and mouth;

• blurred vision;

• dizziness, drowsiness, problems with memory or concentration;

• ringing in your ears;

• feeling restless or irritable; or

• mild nausea, stomach pain, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Cold Symptoms:

Acetaminophen/pheniramine/phenylephrine 325 mg-20 mg-10 mg oral powder:
Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Acetaminophen/pheniramine/phenylephrine 650 mg-20 mg-10 mg oral powder:
Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen/pheniramine/phenylephrine 325 mg-20 mg-10 mg oral powder:
>=12 yrs: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Acetaminophen/pheniramine/phenylephrine 650 mg-20 mg-10 mg oral powder:
>=12 yrs: Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

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, pheniramine, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Applies to acetaminophen / pheniramine / phenylephrine: oral powder for reconstitution

Cardiovascular

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

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

Gastrointestinal

Gastrointestinal side effects of acetaminophen have included rare cases of acute pancreatitis.

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

Genitourinary

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

Hypersensitivity

Hypersensitivity side effects of acetaminophen have included rare reports of anaphylaxis and fixed drug eruptions.[Ref]

Nervous system

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

Renal

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]

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]

Respiratory

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

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

Psychiatric

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

General

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

Dermatologic

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

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

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