GREEN TUSSIN SUGAR FREE DM LIQUID [GREEN CHOICE FOR LIFE]

GREEN TUSSIN SUGAR FREE DM LIQUID [GREEN CHOICE FOR LIFE]
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NDC 55287-101-06
Set ID b69451bc-07a0-4769-975e-2514661e2384
Category HUMAN OTC DRUG LABEL
Packager Green Choice for Life
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients (in each 15 mL)                    
    Dextromethorphan HBr 10mg...............Cough Suppressant
    Guaifenesin 100mg...........................................Expectorant

  • PURPOSE

    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 secretions 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 headache, 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 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 a doctor or pharmacist before taking this product.
  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast-feeding, ask a health professional before use.
    In case 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

    Directions

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

    age 

    adults and children 12 years or more 

    dose

    2 tablespoons (30 mL) every 4 hours

    age

    children under 12 years of age

    dose

    consult a doctor

  • OTHER SAFETY INFORMATION

    Other information

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

    Inactive Ingredients acesulfame potassium, aloe, ascorbic acid, bee propolis, caramel color, carboxymethlycellulose sodium, cat’s claw extract, eucalyptus oil, garlic oil, ginger, glycerin, menthol, methylparaben, natural & artificial honey flavor, onion, peppermint spirits, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, water

  • QUESTIONS

    Questions? Call 305-763-3288 M-F 9 am to 5 pm Eastern

  • PRINCIPAL DISPLAY PANEL

    Green Tussin SUGAR FREE DM Label

  • INGREDIENTS AND APPEARANCE
    GREEN TUSSIN SUGAR FREE  DM
    green tussin sugar free dm liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55287-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ALOE (UNII: V5VD430YW9)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    CARAMEL (UNII: T9D99G2B1R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GARLIC OIL (UNII: 4WG8U28833)  
    GINGER (UNII: C5529G5JPQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    HONEY (UNII: Y9H1V576FH)  
    ONION (UNII: 492225Q21H)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55287-101-061 in 1 CARTON08/16/2013
    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(55287-101)

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