GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]

GUAAP (GUAIFENESIN) LIQUID [A P J LABORATORIES LIMITED]
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NDC 46084-051-21
Set ID 6f6f3aae-a676-4b91-bad3-2a1c798ffe0a
Category HUMAN OTC DRUG LABEL
Packager A P J Laboratories Limited
Generic Name
Product Class
Product Number
Application Number PART341
  • purpose


    Expectorant
  • keep out of reach of children

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

  • uses

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

  • warning

    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 if
    cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.







  • direction

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

    •this adult product is not intended for use in children under 12 years of age
    age dose

    adults and children 12 years and over: 2-4 teaspoons every 4 hours


    children under 12 years: do not use

  • inactive ingredient

    ASPARTAME

  • INACTIVE INGREDIENT

    BRONOPOL

  • INACTIVE INGREDIENT

    EDETIC ACID

  • INACTIVE INGREDIENT

    MENTHOL

  • INACTIVE INGREDIENT


    SUCROSE

  • INACTIVE INGREDIENT

    SODIUM BENZOATE

  • INACTIVE INGREDIENT

    SORBITOL

  • INACTIVE INGREDIENT

    XANTHAN GUM

  • ACTIVE INGREDIENT

    GUAIFENESIN
  • PRINCIPAL DISPLAY PANEL

    product
  • INGREDIENTS AND APPEARANCE
    GUAAP 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-051
    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
    MENTHOL (UNII: L7T10EIP3A) 10 ug  in 5 mL
    SUCROSE (UNII: C151H8M554) 200 mg  in 5 mL
    SORBITOL (UNII: 506T60A25R) 50 mg  in 5 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 5 mL
    BRONOPOL (UNII: 6PU1E16C9W) 0.5 mg  in 5 mL
    EDETIC ACID (UNII: 9G34HU7RV0) 0.5 mg  in 5 mL
    ASPARTAME (UNII: Z0H242BBR1) 1 mg  in 5 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.5 mg  in 5 mL
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-051-21120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-051)

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