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

  • NDC Code(s): 53345-006-01
  • Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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  • Active ingredients (in each capsule)
    Acetaminophen 325 mg - Dextromethorphan HBr 15 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 - 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 hours, which is the maximum daily amount - with other drugs containing ...
  • DO NOT USE
    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 ...
  • Ask a doctor before use if you have
    liver disease - glaucoma - cough with excessive phlegm(mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema - difficulty in ...
  • 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 exceed the recommended dosage - do not use for more than 7 days - excitability may occur especially in children - marked drowsiness may occur - avoid alcoholic drinks - alcohol, sedatives ...
  • STOP USE
    Stop use and Ask a doctor if - you get nervous, dizzy, or sleepless - swelling or redness is present - symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new ...
  • PREGNANCY OR BREAST FEEDING
    If pregnant or breast-feeding,ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN
    Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems.In case of overdose, get medical help or contact a Poison ...
  • Directions
    take only as directed - see overdose warning - do not exceed 4 doses per 24 hours - Adults and children 12 years of age and over -  Swallow 2 softgels with water every 6 hours - Children 4 to ...
  • Other information
    store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat - this product does not contain phenylpropanolamine (PPA)
  • 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 - Manufactured by: Humanwell PuraCap ...
  • PRINCIPAL DISPLAY PANEL - Shipping Label
    NIGHTTIME COLD AND FLU CAPSULES - Quantity : 4000 Capsules - NDC. No : 53345-006-01 - IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing ...
  • INGREDIENTS AND APPEARANCE
    Product Information