Label: NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

  • 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 SECTION
    Drug Facts
  • Active ingredients (in each Softgel)
    Acetaminophen 325 mg - Dextromethorphan HBr 15 mg - Doxylamine succinate 6.25 mg
  • Purposes
    Pain reliever/fever reducer - Cough suppressant  - Antihistamine
  • Uses
    temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - sore throat - headache - minor aches & pains - fever - runny nose & sneezing
  • Warnings
    Liver 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 ...
  • Directions
    take only as directed - see Overdose warning - do not exceed 4 doses per 24 hrs                                                                    adults and children 12 yrs & over -      2 ...
  • Other information
    store at room temperature 15°-30°C (59°-86°F)
  • Inactive ingredients
    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink
  • Questions or comments?
    Call toll free: 1-800-833-6278
  • PRINCIPAL DISPLAY PANEL
    NITE TIME COLD/FLU MEDICINE - 20 SOFTGELS - NDC 51013-147-08 - *Compare to the active ingredients in VICKS® NyQuil® Cold & Flu
  • INGREDIENTS AND APPEARANCE
    Product Information