Label: GUAIFENESIN 400MG CAPLETS- 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 November 17, 2022

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  • ACTIVE INGREDIENT (IN EACH CAPLET)

    GUAIFENESIN 400MG

  • PURPOSE

    EXPECTORANT

  • USES

    • HELPS LOOSEN PHLEGM (MUCUS) AND THIN BRONCHIAL SECRETIONS TO RID THE BRONCHIAL PASSAGEWAY OF BOTHERSOME MUCUS.
    • HELPS MAKE COUGHS MORE PRODUCTIVE
  • WARNINGS

    ASK DOCTOR BEFORE USE IF YOU HAVE:

    • PERSISTENT OR CHRONIC COUGH SUAH AS OCCURS WITH SMOKING, ASTHMA, CHRONIC BRONCHITIS OR EMPHASEMA (MUCUS)
    • COUGH ACCOMPANIED BY EXCESSIVE PHLEGM

    WHEN USING THIS PRODUCT

    • DO NOT EXCEED RECOMMENDED DOSAGE
    • DO NOT USE FOR MORE THAN 7 DAYS

    STOP USE AND ASK A DOCTOR IS

    • COUGH LASTS FOR MORE THAN 7 DAYS, RECURS, OR IS ACCOMPANIED BY FEVER, RASH, OR PERSISTENT HEADACHE. THESE COULD BE SIGNS OF A SERIOUS CONDITION.

    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 (1-800-222-1222) IMMEDIATELY.

  • DIRECTIONS

    • ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER TAKE 1 CAPLET EVERY 4 HOURS WITH A FULL GLASS OF WATER WHILE SYMPTOMS PERSIST.
    • CHILDREN UNDER 12 YEARS OF AGE DO NOT USE.
  • OTHER INFORMATION

    • STORE AT 25°C (77°F) EXCURSIONS BETWEEN 15° - 30° C (59° - 86°F)
    • KEEP IN A DRY PLACE AND DO NOT EXPOSE TO HEAT
  • INACTIVE INGREDIENTS

    CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MALTODEXTRIN, STEARIC ACID, MICROCRYSTALLINE CELLULOSE, POVIDONE, SILICON DIOXIDE

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Guaifenesin_NDC 77333-360-10

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 400MG CAPLETS 
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77333-360
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (CAPLET) Size14mm
    FlavorImprint Code G400
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77333-360-10100 in 1 BOX09/02/2022
    1NDC:77333-360-251 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/02/2022
    Labeler - Gendose Pharmaceuticals, LLC (080257510)
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