daytime severe cold and cough and nighttime severe cold and cough
daytime severe cold and cough and nighttime severe cold and cough is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL manufactured by Target Corporation. 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 20180118.
Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL
Manufacturer: Target Corporation
Product Type: HUMAN OTC DRUG
Route:
Dosage Form:
NDC: 11673-542
Application: part341
Effective: 20180118
Active Ingredients: Active ingredients (in each packet) – Daytime Severe Cold and Cough Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mgActive ingredients (in each packet) - Nighttime Severe Cold and Cough Acetaminophen 650 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg
Indications & Usage
Uses - Daytime Severe Cold and Cough • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever
Dosage & Administration
Directions – Daytime Severe Cold and Cough • do not use more than directed • take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat Directions Nighttime Severe Cold and Cough • do not use more than directed • take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat
Contraindications
Not available.
Warnings
Warnings – Daytime Severe Cold and Cough and Nighttime Severe Cold and Cough 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: ● Skin reddening● blisters● rash Is 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
Not available.
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