Label: NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

  • NDC Code(s): 49580-0843-2
  • Packager: P & L Development, 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 May 22, 2023

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  • Active ingredients (in each 30 mL)
    Acetaminophen 650 mg - Dextromethorphan HBr 30 mg - Doxylamine succinate 12.5 mg
  • Purposes
    Pain reliever/fever reducer - Cough suppressant - Antihistamine
  • Uses
    temporarily relieves these common cold/flu symptoms: minor aches and pains - headache - sore throat - fever - runny nose and sneezing - cough due to minor throat and bronchial irritation
  • Warnings
    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 ...
  • Directions
    do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hours period  - measure only with dosing cup provided. Do not use any other dosing device. mL ...
  • Other information
    each 30 mL contains: potassium 5 mg - each 30 mL contains: sodium 24 mg - store between 20-25ºC (68-77ºF). Do not refrigerate.
  • Inactive ingredients
    acesulfame potassium, alcohol, citric acid. FD&C blue1, FD&C red 40, Flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
  • Questions or comments?
    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
  • Principal Display Panel
    night time - cold & flu relief - acetaminophen (pain reliever / fever reducer) dextromethorphan HBr (cough suppressant) doxylamine succinate (antihistamine) for ages 12 years & over - alcohol ...
  • Product Label
    WELLNESS BASICS Nighttime Cold & Flu Relief
  • INGREDIENTS AND APPEARANCE
    Product Information