Label: GUAIFENESIN tablet

  • NDC Code(s): 69618-061-06
  • Packager: Reliable 1 Laboratories LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2025

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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

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-061-06

    Reliable-1 Laboratories

    Guaifenesin 400 mg

    Expectorant

    60 CAPLETS

    pdp

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (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:69618-061-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/2020
    Labeler - Reliable 1 Laboratories LLC (079718111)
    Registrant - Reliable 1 Laboratories LLC (079718111)
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