GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]

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GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-5847-0
Set ID bf32f7e3-2973-434a-a3c5-7e40bedf5f2a
Category HUMAN OTC DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • 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
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