TUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]

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TUSSIN GUIFENESIN EXPECTRORANT SYRUP (GUIFENESIN) SYRUP [BAYER HEALTHCARE LLC]
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NDC 61841-403-26
Set ID 0ca25fb1-c9b6-481d-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC
Generic Name
Product Class
Product Number
Application Number
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  • Drug Facts

  • Active Ingredients (in each 5ml teaspoonful)

    Guaifenesin, USP 100 mg

  • Purpose

    Expectorant

  • INDICATIONS & USAGE

    Helps loosen phlegn (mucus) to make coughs more productive.

  • WARNINGS

  • ASK DOCTOR

    Ask a doctor before use if

    • you have chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough occurs with too much mach phlegm (mucus)
  • ASK DOCTOR/PHARMACIST

  • STOP USE

    Stop use and ask a doctor if cough lasts for more than 1 week, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a seriuos conditions.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    tussin

  • DOSAGE & ADMINISTRATION

  • INACTIVE INGREDIENT

  • INGREDIENTS AND APPEARANCE
    TUSSIN  GUIFENESIN EXPECTRORANT SYRUP
    guifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61841-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61841-403-261 in 1 CARTON01/14/2015
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/14/2015
    Labeler - Bayer HealthCare LLC (785159372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Pharm, Inc.801652546manufacture(61841-403) , pack(61841-403)
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