Label: ADULT LONG LASTING-COUGH RELIEF- dextromethorphan hbr,usp capsule

  • 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 May 21, 2013

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  • ACTIVE INGREDIENT(S)

    Dextromethorphan HBr, USP 15 mg 

  • PURPOSE

    Cough Suppressant 

  • USE(S)

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

  • WARNINGS


    DO NOT USEYou 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

    • 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 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.

  • PREGNANCY/BREASTFEEDING

    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 liquidgels in any 24-hour period
    • adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed 
    • children under 12 years: ask a doctor
  • STORAGE

    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 
    • store at 20º-25ºC (68º-77ºF)
    • avoid excessive heat above 40ºC (104ºF)
    • protect from light
    • use by expiration date on package
  • INACTIVE INGREDIENTS

    Gelatin, Sorbitol, Sorbitan, FD&C Blue No.1, Water, Polyethylene Glycol 400, Povidone K-30, Glycerine, FD&C Red No. 40, Propylene Glycol.

  • PRINCIPAL DISPLAY PANEL

    CARTON LABEL PDP

    NDC # 68016-026-20

    Adult Long-Lasting Cough Relief
    DEXTROMETHORPHAN HBr, USP 15mg
    COUGH SUPPRESSANT

    Relieves cough for upto 8 hours
    Non-drowsy
    Non-Narcotic formula

    20 softgels

    Dex-cdc-ct-20sfg



    BOTTLE LABEL PDP

    NDC # 68016-026-20

    Adult Long-Lasting Cough Relief
    DEXTROMETHORPHAN HBr, USP 15mg
    COUGH SUPPRESSANT

    Relieves cough for about 8 hours
    Non-Drowsy
    Non-Narcotic Formula

    20 Softgels

    Dex-cdc-bt-20sfg

  • INGREDIENTS AND APPEARANCE
    ADULT LONG LASTING-COUGH RELIEF 
    dextromethorphan hbr,usp capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-026
    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
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorREDScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code 26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-026-201 in 1 CARTON
    120 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/22/2013
    Labeler - Chain Drug Consortium LLC (101668460)
    Registrant - Chain Drug Consortium LLC (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marksans Pharma Limited925822975MANUFACTURE(68016-026)
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