Label: COUGH RELIEF- dextromethorphan hydrobromide capsule, liquid filled

  • 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 21, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 useif 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

    • 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 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 8 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

         take 2 softgels every 6 to 8 hours, as needed

    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)
    • 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

  • Questions or comments?

    Call toll free: 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL - Carton Label

    TopCare Cough Relief

    Dextromethorphan HBr, USP 15 mg 20 SOFTGELS

    NDC 36800-415-15

    *Compare to the active ingredient in Robitussin® Lingering Cold Long-Acting CoughGels®

    Carton Label Front

    Carton Label Back

  • PRINCIPAL DISPLAY PANEL - Bottle Label

    TopCare Cough Relief

    Dextromethorphan HBr, USP 15 mg 20 SOFTGELS

    NDC 36800-415-15

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    COUGH RELIEF 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-415
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (clear) Scoreno score
    Shapecapsule (oval) Size14mm
    FlavorImprint Code PC6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-415-151 in 1 CARTON07/06/2016
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/06/2016
    Labeler - Topco Associates LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(36800-415) , analysis(36800-415)
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