Cold, Flu and Sore Throat Maxium Strength

Cold, Flu and Sore Throat Maxium Strength is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE manufactured by DeMoulas Market Basket administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231229.

Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Manufacturer: DeMoulas Market Basket

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 53942-516

Application: M012

Effective: 20231229

Active Ingredients: Drug FactsActive ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifensin 400 mg Phenylephrine HCL 10 mg

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation nasal congestion sinus congestion and pressure minor aches and pains sore throat headache fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage & Administration

Directions take only as recommended (see overdose warning) use dose cup mL = milliliter do not take more than 6 doses in any 24-hour period Age - Adults and children 12 years and older Dose - 20 mL every 4 hours Age - Children under 12 years of age Dose - Do not use

Contraindications

Not available.

Warnings

Warnings Liver warning This product contains acetaminophen. Sever 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 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.

Adverse Reactions