Label: GUAIFENESIN 400MG CAPLETS- guaifenesin tablet

  • NDC Code(s): 77333-360-10, 77333-360-25
  • Packager: Gendose Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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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 DrugM01209/02/2022
    Labeler - Gendose Pharmaceuticals, LLC (080257510)
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