Label: NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 51013-147-08 - Packager: PuraCap Pharmaceutical LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 13, 2019
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SPL UNCLASSIFIED SECTIONDrug Facts
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Active ingredients (in each Softgel)Acetaminophen 325 mg - Dextromethorphan HBr 15 mg - Doxylamine succinate 6.25 mg
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PurposesPain reliever/fever reducer - Cough suppressant - Antihistamine
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Usestemporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever - runny nose & sneezing
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WarningsLiver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 4 doses in 24 hrs, which is the maximum daily amount for this product - with other drugs ...
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Directionstake only as directed - see Overdose warning - do not exceed 4 doses per 24 hrs adults and children 12 yrs & over - 2 ...
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Other informationstore at room temperature 15°-30°C (59°-86°F)
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Inactive ingredientsD&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
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Questions or comments?Call toll free: 1-800-833-6278
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PRINCIPAL DISPLAY PANELNITE TIME COLD/FLU MEDICINE - 20 SOFTGELS - NDC 51013-147-08 - *Compare to the active ingredients in VICKS® NyQuil® Cold & Flu
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INGREDIENTS AND APPEARANCEProduct Information