Label: LIQUFRUTA- guaifenesin syrup

  • 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 July 15, 2011

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  • ACTIVE INGREDIENT

    GUAIFENESIN 50 MG/TEASPOON (5ML)
  • PURPOSE

    EXPECTORANT -HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO MAKE COUGH MORE PRODUCTIVE
  • KEEP OUT OF REACH OF CHILDREN

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

    Loosens and Relieves Chest congestion
  • WARNINGS

    Ask a doctor before use if you have a cough that last or it is chronic such as occurs with smoking, asthma, chronic Bronchitis or emphysema. Stop use and ask doctor if a cough lasts for more than 7 days comes back or occurs when fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
    If pregnant of breast-feeding, ask a health professional before use.
  • DOSAGE & ADMINISTRATION

    do not take more than 6 doses in a 24-hour period
    AGE ......................................................DOSE
    Adults and Children 12 years and over .......2-4 teaspoonfuls(tsp) every 4 hours
    Children 6 years and under 12 years......... 1-2 teaspoonfuls(tsp) every 4 hours
    Children 2 years and under 6 years........... 1/2-1 teaspoonfuls(tsp) every 4 hours
    Under 2 years ........................................ask a doctor
  • INACTIVE INGREDIENT

    Purified water, natural garlic oil,caramel, high fructose sucrose, menthol, ethanol, sodium citrate, citric acid, sodium benzoate, acetic acid
  • QUESTIONS

    OTHER Information
    Shake well Before Use
    store at room temp (59F-86)


    imported and Distributed by:
    Bedessee Imports Ltd.
    Brooklyn, NY USA 11208
    1-888-BEDESEE
    416-292-2400
  • PRINCIPAL DISPLAY PANEL

    PDP CARTON
  • INGREDIENTS AND APPEARANCE
    LIQUFRUTA 
    guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75939-9876
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M) 5 mg  in 100 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    GARLIC OIL (UNII: 4WG8U28833)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    MENTHOL (UNII: L7T10EIP3A)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75939-9876-1150 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2011
    Labeler - Alston Garrard & Co (735697570)
    Registrant - Alston Garrard & Co (735697570)
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