Label: GERI-TUSSIN EXPECTORANT- guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 20, 2018

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  • Active ingredient (per teaspoonful = 5mL)

    Guaifenesin, USP 100 mg

  • Purpose

    Expectorant

  • Uses

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

  • Warnings

    Do not use if you are hypersensitive to any of the ingredients

    Ask a doctor before use if you have

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

    Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

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

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • do not exceed recommended dose
    adults and children 12 years and over
    		2-4 teaspoonfuls every 4 hours
    children under 12 years
    		ask a doctor

  • Other information

    • store at room temperature 15º - 30ºC (59º - 86ºF)

    • protect from freezing

    • protect from light

    • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

  • Inactive ingredients

    citric acid, caramel, FD and C Red 40, flavor, glycerin, menthol, sodium saccharin, sodium benzoate, sorbitol, water

  • HOW SUPPLIED

    Product: 17856-0793

    NDC: 17856-0793-1 15 mL in a CUP, UNIT-DOSE

    NDC: 17856-0793-2 10 mL in a CUP, UNIT-DOSE

    NDC: 17856-0793-3 5 mL in a CUP, UNIT-DOSE

  • GERI-TUSSIN EXPECTORANT (GUAIFENESIN) LIQUID

    NDC 17856-0793-1

    image description

    NDC 17856-0793-2

    image description

    NDC 17856-0793-03

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  • INGREDIENTS AND APPEARANCE
    GERI-TUSSIN EXPECTORANT 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0793(NDC:57896-793)
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0793-115 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product05/02/2018
    2NDC:17856-0793-210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product05/02/2018
    3NDC:17856-0793-35 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product05/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2000
    Labeler - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-0793) , REPACK(17856-0793)
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