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Gadavyt Cough (Gadal Laboratories Inc)

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LIQUID 118 mL in 1 BOTTLE (53113-550-04) Label Information

Complete Gadavyt Cough Information

  • ACTIVE INGREDIENT

    Active Ingredient (in each 5 mL tsp.)              Purpose

    Guaifenesin 100mg                                          Expectorant


  • PURPOSE

    USES
    Helps loosen phlegm (mucus) and thin bronchial
    secretions to make coughs more productive


  • WARNINGS

    Warnings
    Ask a doctor before use if

    • you have cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
    • cough occurs with too much phlegm (mucus)

  • DO NOT USE

    Stop use and ask a doctor if

    • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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


  • PREGNANCY OR BREAST FEEDING

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


  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 6 doses in any 24 hour period

    adults and children 12 years and over
    2-4 TSP every 4 hours or as directed by doctor
    children under 12 years
    do not use

  • INDICATIONS & USAGE

    Other information
    store at room temperature  15 - 30 degrees C (59 - 86 degrees F)
    TAMPER-EVIDENT: Do not use if seal under cap is torn,
    broken or missing.


  • INACTIVE INGREDIENT

    Inactive Ingredients
    Citric acid, menthol, methylparaben, propylparaben, glycerin,
    sucralose, sodium citrate, FD and C Red No. 40, caramel color,
    cherry flavor, natrosol, purified water.


  • QUESTIONS

    GADAL Laboratories, Inc.

    Miami, Fl 33186

    www.gadallaboratories.com


  • INGREDIENTS AND APPEARANCE
    GADAVYT COUGH 
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-550
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Cherry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53113-550-04 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/01/2012
    Labeler - Gadal Laboratories Inc (841305639)