Label: GUAIFENESIN tablet

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

Drug Label Information

Updated April 3, 2024

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  • Drug Facts

  • Active ingredient (in each caplet)

    Guaifenesin 400 mg

  • Purpose

    Expectorant

  • Uses

    helps lossen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersone 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 then 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signes of serious illness.

  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious illness.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 caplet every 4 hours
    • children under 12 years: do not use
  • Other information

    store at 15°-30°C (59°-86°F)

  • Inactive ingredients

    colloidal silicon dioxide, magnesium stearate, maltodextrin, microsrystalline cellulose, providone, stearic acid

  • Questions or comments?

    call 516-341-0666, 8:30 am-4:30 pm ET, Monday-Friday

  • SPL UNCLASSIFIED SECTION

    Drug Facts continued on back of label

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

    Distributed by: Reliable-1 Laboratoreis LLC

    Valley Stream, Ny 11580 www.reliable1labs.com

  • HOW SUPPLIED

    Guaifenesin 400 mg

    NDC: 71335-9616-1: 30 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-9616-2: 20 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-9616-3: 50 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-9616-4: 60 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-9616-5: 40 Tablets in a BOTTLE, PLASTIC

    Store at 15°-30°C (59°-86°F)

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin 400 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-9616(NDC:69618-061)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code A;152
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-9616-130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    2NDC:71335-9616-220 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/28/2022
    3NDC:71335-9616-350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    4NDC:71335-9616-460 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    5NDC:71335-9616-540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/2020
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-9616) , RELABEL(71335-9616)
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