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
  • 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 November 8, 2019

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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

    Shipping 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 finalpart34106/30/2015
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287MANUFACTURE(53345-034) , ANALYSIS(53345-034)
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