Label: GADAVYT COUGH- 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 December 17, 2012

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  • 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

  • PRINCIPAL DISPLAY PANEL

    coughlabel

  • INGREDIENTS AND APPEARANCE
    GADAVYT COUGH 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-550
    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
    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    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-550-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2012
    Labeler - Gadal Laboratories Inc (841305639)
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