Label: GUAIFENESIN 400MG- guaifenesin tablet

  • NDC Code(s): 10135-790-30, 10135-790-60
  • Packager: Marlex Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 1, 2024

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  • SPL UNCLASSIFIED SECTION

    GUAIFENESIN400MG CAPLETS

    MarlexPharmaceuticals, Inc.

    ----------

    Drug Fact

  • Active ingredient (in each tablet)

    Guaifenesin 400mg

  • Purpose

    Expectorant

    Guaifenesin 400 mg Caplets

  • 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, comes back or is accompanied by fever, rash, or persistent headache. These 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:

    Maltodextrin, Povidone, Silicon Dioxide, Stearic acid.

    Manufactured for & Distributed by:

    Marlex Pharmaceuticals, Inc.

    New Castle, DE 19720

    Rev. 03/24 AA

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0790-30
    Guaifenesin
    400 mg
    30 CAPLETS

    790-30

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0790-60
    Guaifenesin
    400 mg
    60 CAPLETS

    790-60

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 400MG 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-790
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeCAPSULE (Caplet) Size14mm
    FlavorImprint Code C16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-790-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    2NDC:10135-790-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2024
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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