Label: GUAIFENESIN - ODAAT 1200 MG- guaifenesin tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 4, 2023

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  • ACTIVE INGREDIENT (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)

    GUAIFENESIN 1200MG

  • PURPOSE

    EXPECTORANT

  • USES

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

    DO NOT USE

    • FOR CHILDREN UNDER 12 YEARS OF AGE

    ASK DOCTOR BEFORE USE IF YOU HAVE:

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

    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

    • DO NOT CRUSH, CHEW, OR BREAK TABLET
    • TAKE WITH A FULL GLASS OF WATER
    • THIS PRODUCT CAN BE ADMINISTERED WITHOUT REGARD FOR TIMING OF MEALS
    • ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: TAKE 1 TABLET EVERY 12 HOURS. DO NOT EXCEED 2 TABLETS IN 24 HOURS.
    • CHILDREN UNDER 12 YEARS OF AGE: DO NOT USE.
  • OTHER INFORMATION

    • STORE BETWEEN 20-25°C (68-77°F)
  • INACTIVE INGREDIENTS

    CARBOMER HOMOPOLYMER TYBE B, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, SODIUM STARCH GLYCOLATE.

  • QUESTIONS?

    CALL TOLL-FREE +1 630 852 7544

  • PRINCIPAL DISPLAY PANEL

    PDP

    DF BOX

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN - ODAAT  1200 MG
    guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83139-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize21mm
    FlavorImprint Code G;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83139-175-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342003/04/2023
    Labeler - LODAAT LLC (011845714)
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