Label: DEXTROMETHORPHAN HBR 15 MG- dextromethorphan hbr capsule, liquid filled

  • NDC Code(s): 53345-028-01
  • Packager: Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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  • Active ingredient (in each softgel)

    Dextromethorphan HBr, USP 15 mg

  • Purpose

    Cough suppressant

  • Use

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

  • Warnings

    Do not useifyou 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 the user has

    • a cough that occurs with too much phlegm (mucus)
    • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

    Stop use and ask a doctor ifcough 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 8 capsules in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age

    adults and children 12 years of age and over

         take 2 capsules every 6 to 8 hours, as  needed

    children under 12 years of  age

         do not use
  • Other information

    • store at 20-25°C (68-77°F)
    • avoid excessive heat above 40°C (104°F)
    • protect from light
  • Inactive ingredients

    FD&C blue #1, 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

  • Questions or comments?

    Call toll free 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Dextromethorphan HBr Capsules, 15 mg

    Quantity : 12000 Capsules
    NDC No. : 53345-028-01

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

    Shipping Label

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR 15 MG 
    dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-028
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (CLEAR) Scoreno score
    ShapeCAPSULE (OVAL) Size10mm
    FlavorImprint Code 661
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-028-011 in 1 BOX12/10/2014
    112000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/10/2014
    Labeler - Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.421293287manufacture(53345-028)
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