Nite-Time COLD/FLU ORIGINAL
Nite-Time COLD/FLU ORIGINAL is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE manufactured by Salado Sales, 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 20231229.
Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Manufacturer: Salado Sales, Inc.
Product Type: HUMAN OTC DRUG
Route: ORAL
Dosage Form:
NDC: 57243-501
Application: M013
Effective: 20231229
Active Ingredients: Drug FactsActive ingredients (in each 30 mL dose cup) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Indications & Usage
Uses temporarily relieves cold/flu symptoms: sore throat minor aches and pain runny nose and sneezing cough due to minor sore throat and bronchial irritation headache fever
Dosage & Administration
Directions take only as recommended-see Overdose warnings Use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours AptaPharma NiteTime2 Label
Contraindications
Not available.
Warnings
Warnings Failure to follow these warnings could result in serious consequences Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amoun 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 If a skin reaction ccurs, 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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