Label: GUAAP - guaifenesin liquid

  • NDC Code(s): 46084-051-21
  • Packager: A P J Laboratories Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • purpose


    Expectorant Close
  • keep out of reach of children

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

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  • uses

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

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  • 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.







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  • 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

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  • inactive ingredient

    ASPARTAME

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  • INACTIVE INGREDIENT

    BRONOPOL

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  • INACTIVE INGREDIENT

    EDETIC ACID

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  • INACTIVE INGREDIENT

    MENTHOL

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  • INACTIVE INGREDIENT


    SUCROSE

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  • INACTIVE INGREDIENT

    SODIUM BENZOATE

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  • INACTIVE INGREDIENT

    SORBITOL

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  • INACTIVE INGREDIENT

    XANTHAN GUM

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  • ACTIVE INGREDIENT

    GUAIFENESIN Close
  • INGREDIENTS AND APPEARANCE
    GUAAP 
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46084-051
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    MENTHOL 10 ug  in 5 mL
    SUCROSE 200 mg  in 5 mL
    SORBITOL 50 mg  in 5 mL
    SODIUM BENZOATE 1 mg  in 5 mL
    BRONOPOL 0.5 mg  in 5 mL
    EDETIC ACID 0.5 mg  in 5 mL
    ASPARTAME 1 mg  in 5 mL
    XANTHAN GUM 0.5 mg  in 5 mL
    Product Characteristics
    Color yellow Score     
    Shape Size
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46084-051-21 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    Name Address ID/FEI Business Operations
    A P J Laboratories Limited 677378339 manufacture(46084-051)
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