Childrens Multi-symptom Cold and Fever Liquid

Childrens Multi-symptom Cold and Fever Liquid is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL manufactured by Wal-Mart Stores, Inc. 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 20180108.

Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL

Manufacturer: Wal-Mart Stores, Inc.

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 49035-772

Application: part341

Effective: 20180108

Active Ingredients: ACTIVE INGREDIENTS (in each 10 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenyephrine HCl 5 mg

Indications & Usage

USE(S) temporarily relieves these common cold and flu symptoms: nasal congestion stuffy nose cough due to minor throat and bronchial irritation the intensity of coughing the impulse to cough to help your child get to sleep minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Dosage & Administration

DIRECTIONS this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) shake well before use do not give more than 5 doses in any 24-hour period if needed, repeat dose every 4 hours while symptoms last do not give more than 5 days unless directed by a doctor measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor Children 6 to under 12 years of age: 10 mL in dosing cup provided. mL = milliliter Children under 6 years of age: do not use.

Contraindications

Not available.

Warnings

WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hous, which is the maximum daily amount with other drugs containing acetaminophen. 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