Label: GUAIFENESIN- 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 November 7, 2018

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

  • Active ingredient (in each immediate-release tablet)

    Guaifenesin 200 mg

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  • Purpose

    Expectorant

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  • Uses

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

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  • 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.

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  • 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 age consult a physician

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  • Other information

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

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

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  • Questions or comments?

    (800) 616-2471 Close
  • Principal Display Panel

    NDC 0904-5154-60

    MAJOR®

    GUAIFENESIN
    TABLETS
    Guaifenesin 200 mg

    Expectorant

    • Relieves Chest Congestion
    • Thins and Loosens Mucus

    100Tablets

    Immediate Release 

    50844    REV0812B58812
    Distributed by MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive, Livonia, MI 48150 USA
    Re-Order No. 238163    M-17    Rev. 04/13

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Major 44-588

    Major 44-588

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  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5154
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color PINK (dark) Score 2 pieces
    Shape ROUND Size 10mm
    Flavor Imprint Code 44;588
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5154-60 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/05/2009
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0904-5154)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0904-5154)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(0904-5154)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(0904-5154)
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