DEXTROMETHORPHAN HBR 15 MG

FDA Drug Profile — DEXTROMETHORPHAN HBR 15 MG

Drug Details

Generic Name
DEXTROMETHORPHAN HBR 15 MG
Brand Names
DEXTROMETHORPHAN HBR 15 MG
Application Number
M012
Sponsor
AMZ789 LLC
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches & pains ■ fever ■ runny nose & sneezing

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 8 softgels in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash 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. Ask a doctor before use if you have ■ liver disease ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema ■ trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin When using this product ■ do not exceed recommended dosage ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery ■ alcohol, sedatives & tranquilizers may increase drowsiness Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ 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. Quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.