Label: GUAIFENESIN 200MG- guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2025

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  • SPL UNCLASSIFIED SECTION

    GUAIFENESIN 200 MG TABLETS

    MarlexPharmaceuticals, 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 Suppliedsection 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 DrugM01203/01/2019
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585repack(71610-434)
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