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 March 1, 2012

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

View All Sections
  • Active ingredient (in each immediate-release tablet)

    Guaifenesin 200 mg
  • Purpose

    Expectorant
  • Use(s)

    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 age consult a physician 

  • Other information

    • store at controlled room temperature 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?

    To Report Adverse Drug Event Call: (800) 616-2471
  • Principal Display Panel

    The product packaging shown below represents a sample of that currently in use.  Additional packaging may also be available.
    NDC 54868-5847-0
    Product Packaging


    GUAIFENESIN TABLETS
    Guaifenesin 200 mg
    Expectorant
    • Relieves Chest Congestion
    • Thins and Loosens Mucus
    100 Tablets Immediate Release

    50844     REV0510A58812

    Distributed by MAJOR PHARMACEUTICALS
    31788 Enterprise Drive,
    Livonia, MI 48150 USA
    Re-Order No. 238163        M-17            Rev. 11/10
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5847(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)  
    Product Characteristics
    ColorPINK (dark) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;588
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5847-01 in 1 CARTON
    1100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/07/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!