Label: GUAIFENESIN tablet

  • 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 August 1, 2017

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  • Active ingredient (in each immediate-release tablet)

    Guaifenesin 200 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • Warnings

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by too much phlegm (mucus)

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

    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 exceed 6 doses in 24 hours
    • take with a full glass of water
    adults and children 12 years
    of age and over     		1 to 2 tablets every
    4 hours
    children 6 to under 12 years
    of age

    ½ to 1 tablet every
    4 hours

    children under 6 years of ageconsult a physician

  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • use by expiration date on package
  • Inactive ingredients

    FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silica gel, sodium starch glycolate, stearic acid

  • Questions or comments?

    (800) 616-2471

  • PRINCIPAL DISPLAY PANEL

    DRUG: Guaifenesin

    GENERIC: Guaifenesin

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 49349-511-02

    COLOR: pink

    SHAPE: ROUND

    SCORE: No score

    SIZE: 10 mm

    IMPRINT: 44;588

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • GUAIFENESIN 200mg in 1

    INACTIVE INGREDIENT(S):

    • FD&C RED NO. 40
    • MAGNESIUM STEARATE
    • STEARIC ACID
    • POVIDONE
    • CELLULOSE, MICROCRYSTALLINE
    • MALTODEXTRIN
    • SILICON DIOXIDE

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49349-511(NDC:0904-5154)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorpink (dark) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;588
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49349-511-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product08/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/12/2010
    Labeler - REMEDYREPACK INC. (829572556)
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