Label: MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM capsule, liquid filled

  • NDC Code(s): 53345-034-01
  • Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Dextromethorphan HBr, USP 10 mg

    Guaifenesin, USP 200 mg

  • Purpose

    Cough suppressant

    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Warnings

    Do not use 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 or pharmacist before taking this product.       

    Ask a doctor before use if you have
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not take more than 12 softgels in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age

    age

    dose

    adults and children 12 years and over

    2 softgels every 4 hours

    children under 12 years

    do not use

  • Other information

    • store at room temperature 15-30°C (59-86°F)
    • avoid excessive heat above 40°C (104°F)

  • Inactive ingredients

    FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
    Wuhan, Hubei
    430206, China

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules
    Quantity : 4000 Capsules
    NDC. No : 53345-034-01

    IMPORTANT:

    Inspect immediately upon receipt.
    This is a bulk shipment, intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.
    Store at 15-30°C (59-86°F)

    CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

    Cough Chest Congestion DM Bulk Label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM 
    maximum strength-cough and chest congestion dm capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-034
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (OBLONG) Size18mm
    FlavorImprint Code PC37
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-034-011 in 1 BOX06/30/2015
    14000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/30/2015
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(53345-034)
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