Label: GREEN TUSSIN DM- guaifenesin, dextromethorphan hbr 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 August 9, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients (in each 15 mL)

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

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

  • PURPOSE

    Cough Suppressant

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial sections to make coughs more productive.

  • WARNINGS

    Warnings

    Do not exceed recommended dosage.

    A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent head ache, consult a doctor.

  • DO NOT USE

    Do not use

    • this product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
    • 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 your doctor or pharmacist before taking this product.

  • PREGNANCY OR BREAST FEEDING

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

    Incase of accidental overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    • Do not exceed 6 doses in 24 hours
    • Use dose cup or tablespoon

    adults & children 12 Years of age or more.............2 tablespoonfuls (30mL) every 4 hours

    children under 12 years of age..............................consult your doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store this product between 15­­° to 30°C (59° to 86°F)
    • each 15mL tablespoon contains: sodium 10 mg
  • INACTIVE INGREDIENT

    Inactive Ingredients  aloe, ascorbic acid, caramel color, cat's claw extract, corn syrup, ethyl alcohol, eucalyptus oil, garlic FE, ginger root FE, honey, menthol, methyl paraben, onion FE, peppermint spirits, potassium sorbate, propylene glycol, propyl paraben, sodium benzoate, sucralose

  • QUESTIONS

    Questions? call 305-763-3228 M-F 9 am to 5 pm Eastern

  • PRINCIPAL DISPLAY PANEL

    Green Tussin DM label

  • INGREDIENTS AND APPEARANCE
    GREEN TUSSIN  DM
    guaifenesin, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55287-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) Guaifenesin100 mg  in 15 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALOE (UNII: V5VD430YW9)  
    GINGER (UNII: C5529G5JPQ)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    MENTHOL (UNII: L7T10EIP3A)  
    ONION (UNII: 492225Q21H)  
    GARLIC (UNII: V1V998DC17)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CARAMEL (UNII: T9D99G2B1R)  
    HONEY (UNII: Y9H1V576FH)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55287-100-061 in 1 CARTON08/26/2013
    1180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/21/2012
    Labeler - Green Choice for Life (828750526)
    Registrant - Green Choice for Life (828750526)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC117605075MANUFACTURE(55287-100)
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