Label: BRONCOMAR DM- dextromethorphan hbr, guaifenesin liquid

  • 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 June 12, 2014

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  • ACTIVE INGREDIENT

    Acvtive ingredients: (in each 5ml)              Purpose

    Dextromethorphan HBr 10 mg ................... Cough Suppressant

    Guaifenesin 100 mg ................................... Expectorant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • Help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
    • Teporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
  • WARNINGS

    Warnings

    Do not exceed recommended dosage

  • DO NOT USE

    Do not use

    • If you are now taking a prescription monoamine oxidase inhibitor (MAOI)( certain drugs for depression , psychiatric conditions, or Parkinson’s disease) or for 2 weeks after stopping the MAOI drug.
    • if you do not know if your prescription drug contains on MAOI ask your doctor or pharmacist before taking this product
    • if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor
    • avoid alcoholic beverages while you are taking this product

    Ask the 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

    Stop use and ask the doctor if

    • Nervoisness, dizziness or sleeplessness occurs.
    • Cough persists for more than 1 week, tends to recur, or accompanied by fever, rash or persistent headache. A persistent cough may be sign of a serious condition
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Do not take more than 6 doses in any 24-hour period
    • Shake well before use

    Age                                                                        Dose

    Adults and children 12 years and over           10 mL (2 tsps) every 4 hours

    Children 6 to under 12 years of age.               5 mL (1 tsps) every 4 hours

    Children under 6 years of age                       Do not use

  • INACTIVE INGREDIENT

    Inactive ingredients

    Blue cohosh, citric acid, echinacea, eucalyptus oil, ginkgo biloba, gold seal root, honey, honey flavor, horehound herb, licorice root, menthol, mullein, myrrh, potassium sorbate, slippery elm bark, sodium benzoate, propylene glycol, water, sodium chloride, sucralose, wild cherry bark and zinc sulfate.

  • PRINCIPAL DISPLAY PANEL

    BroncomarDM

  • INGREDIENTS AND APPEARANCE
    BRONCOMAR  DM
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-217
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    EUCALYPTUS CAMALDULENSIS LEAF OIL (UNII: SN6D1J15I6)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    HONEY (UNII: Y9H1V576FH)  
    HOREHOUND (UNII: K08036XEJV)  
    LICORICE (UNII: 61ZBX54883)  
    MENTHOL (UNII: L7T10EIP3A)  
    MULLEIN LEAF (UNII: 9936O846LI)  
    MYRRH (UNII: JC71GJ1F3L)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PRUNUS SEROTINA BARK (UNII: 5D48E975HA)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-217-061 in 1 CARTON
    1177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2014
    Labeler - Gadal Laboratories Inc (841305639)