Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr

FDA Drug Profile — Multi-Symptom Flu HBP, flu HBP Maximum Strength, Antigrip Cough and Cold, Flu HBP Maximum Strength, COLD AND FLU HBP

Drug Details

Generic Name
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
Brand Names
Multi-Symptom Flu HBP, flu HBP Maximum Strength, Antigrip Cough and Cold, Flu HBP Maximum Strength, COLD AND FLU HBP, Flu HBP, Theraflu Flu Relief Max Strength Nighttime
Application Number
M012
Sponsor
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC Codes
11
Dosage Forms
TABLET, FILM COATED, CAPSULE, GELATIN COATED, SYRUP, POWDER
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

Indications and Usage

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains sore throat sneezing headache runny nose cough temporarily reduces fever

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product avoid alcoholic beverages marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.