Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI

FDA Drug Profile — Mucus Relief Congestion and Cough Maximum Strength, Tussin Multi Symptom Cold CF

Drug Details

Generic Name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI
Brand Names
Mucus Relief Congestion and Cough Maximum Strength, Tussin Multi Symptom Cold CF
Application Number
M012
Sponsor
TARGET Corporation
NDC Codes
2
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses KICKSTART SEVERE COLD & FLU: temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■ minor aches and pains ■ sore throat ■ headache ■ stuffy nose ■ sinus congestion and pressure ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive NIGHT TIME SEVERE COLD & FLU: temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■ minor aches and pains ■ sore throat ■ headache ■ sinus congestion and pressure ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep

Warnings

Warnings KICKSTART SEVERE COLD & FLU: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 6 doses in 24 hours, which is the maximum daily amount ■ 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 ■ heart disease ■ diabetes ■ high blood pressure ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition. NIGHT TIME SEVERE COLD & FLU: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4,000 mg in 24 hours, which is the maximum daily amount ■ 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 ■ heart disease ■ diabetes ■ high blood pressure ■ thyroid disease ■ glaucoma ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion, 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 fever, rash, or headache that lasts . These could be signs of a serious condition.