Label: GUAIFENESIN 200MG- 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 June 19, 2020

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  • SPL UNCLASSIFIED SECTION

    GUAIFENESIN 200 MG TABLETS

    Marlex Pharmaceuticals, Inc.

    ----------

    Drug Fact

  • Active ingredient (in each tablet)

    Guaifenesin 200mg

  • Purpose

    Expectorant

    Guaifenesin 200 mg Tablets

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway 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 last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

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

     

    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 take more than 6 doses in any 24-hour period.
    • This product is not intended for use in children under 12 years of age
    • Adults & children 12 years and over: 1 to 2 tablets every 4 hours
    • Children under 12 years: do not use
  • Other Information:

    • Store at 15°C-30°C (59°F-86°F)
  • Inactive Ingredients:

    Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

    Manufactured for & Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev: 02/19TCL

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count200 mg
    300071610-434-18

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20200619JH

  • PRINCIPAL DISPLAY PANEL - 200 mg

    NDC 71610-434 - Guaifenesin 200 mg Tablets
    Bottle Label 200 mg

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 200MG 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-434(NDC:10135-681)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71610-434-183000 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/01/2019
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-434)
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