NIGHTTIME COLD AND FLU MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (HEALTH MART)]

NIGHTTIME COLD AND FLU MULTI SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (HEALTH MART)]
PDF | XML

NDC 62011-0262-1
Set ID cfbafd0e-d0a1-444e-bc18-47986b6c27f5
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active Ingredients (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 15 mg

    Doxylamine Succinate 6.25 mg

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistimine

  • Uses

    • temporarily relieves common cold and flu symptoms:
      • sore throat
      • headache
      • minor aches and pains
      • 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 more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • Skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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 prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor of pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Ask a doctor of pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • pain or cough gets worse or lasts more than 7 days
    • 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 lasts. These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose can cause liver damage. 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 symptoms.

  • Directions

    • do not take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • adults and children 12 years and over: take 2 softgels with water every 6 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
  • Other Information

    • store between 15-30ºC (59-86ºF)
    • avoid excessive heat
  • Inactive Ingredients

    D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

    *may contain this ingredient

  • Questions or Comments?

    Call 1-877-753-3929 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to Vicks® NyQuil® LiquiCaps® active ingredients†

    Multi-symptom cold & flu

    night time liquid caps

    Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate

    Pain Reliever / Fever Reducer

    Cough Suppressant / Antihistamine

    SOFTGELS

    †This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Another Quality Product Distributed by McKesson

    One Post Street, San Francisco, CA 94104

    www.healthmart.com/healthmartbrand

  • Package Label

    Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Doxylamine succinate 6.25 mg

    HealthMart NightTime Cold & Flu multi-symptom

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME COLD AND FLU  MULTI SYMPTOM
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0262
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code P30;94A;SCU1;215;P120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0262-116 in 1 CARTON12/31/201502/23/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/31/201502/23/2024
    Labeler - Strategic Sourcing Services LLC (116956644)