Label: ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE capsule, liquid filled

  • NDC Code(s): 35916-0185-2
  • Packager: Softgel Healthcare Private Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 17, 2025

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  • Active ingredients (in each Softgel)
    Acetaminophen 325 mg - Dextromethorphan HBr 10 mg - Doxylamine succinate 6.25 mg
  • Purpose
    Pain reliever/Fever reducer - Cough suppressant - Antihistamine
  • Uses
    temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation - cough to help you sleep - minor aches & pains - headache - fever - sore throat - runny nose ...
  • Warnings
    Liver warning: This product contains acetaminophen.Severe liver damage may occur if you take - more than 8 softgels in 24 hours, which is the maximum daily amount for this product - with other ...
  • Do not use
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a ...
  • Ask a doctor before use if you have
    liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with ...
  • Ask a doctor or pharmacist before use if you are
    taking sedatives or tranquilizers - taking the blood thinning drug warfarin
  • When using this product
    do not use more than directed - excitability may occur, especially in children - marked drowsiness may occur - avoid alcoholic drinks - be careful when driving a motor vehicle or operating ...
  • Stop use and ask a doctor if
    you get nervous, dizzy or sleepless - fever gets worse or lasts more than 3 days - redness or swelling is present - new symptoms occur - cough comes back or occurs with rash or headache that ...
  • If pregnant or breast-feeding,
    ask a health professional before use.
  • Keep out of reach of children.
    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or ...
  • Directions
    take only as directed - do not exceed 8 softgels per 24 hrs - adults & children 12 yrs & over2 softgels with water every 4 hrs - children 4 to under 12 yrsask a doctor - children under 4 yrsdo ...
  • Other information
    do not exceed 25ºC
  • Inactive ingredients
    D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, purified water, sorbitol sorbitan solution
  • Bulk Package Label
    Bulk label
  • INGREDIENTS AND APPEARANCE
    Product Information