GUAIFENESIN TABLET [REMEDYREPACK INC.]

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GUAIFENESIN TABLET [REMEDYREPACK INC.]
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NDC 49349-511-02
Set ID 15c87250-7c30-4565-b451-b87c6754a371
Category HUMAN OTC DRUG LABEL
Packager REMEDYREPACK 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

  • 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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