Label: GUAIFENESIN tablet, extended release

  • NDC Code(s): 62207-839-72, 62207-840-71, 62207-840-93, 62207-840-99
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 26, 2023

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  • ACTIVE INGREDIENT(S)

    Guaifenesin 600 mg (for 600mg)
     
    Guaifenesin 1200 mg (for 1200 mg)

  • PURPOSE

    Expectorant

  • USE(S)

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • WARNINGS


    Do not use

    • for children under 12 years of age
  • 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 DOCTOR IF

    • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
  • PREGNANCY/BREASTFEEDING

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away
    (1-800-222-1222)

  • 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: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours(For 600mg)
    • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.(For 1200mg)
    • children under 12 years of age: do not use
  • OTHER INFORMATION

    •  Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
    •   store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENTS

    carbomer homopolymer type B; hypromellos, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

  • QUESTIONS OR COMMENTS


    Contact 1-877-770-3183
    Mon-Fri 8:00 AM EST to 5:00 PM PST.

    All trademarks are property of their respective owners.MUCINEX is the registered trademark of Reckitt Benckiser LLC.

  • PRINCIPAL DISPLAY PANEL

    guaifenesin-1200mg-jpgguaifenesin-600mg-jpg

    guaifenesin-label3-jpgguaifenesin-foil-jpgguaifenesin-foil2-jpg

    1200-mg-bulk-label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-839
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code G;600
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-839-729 in 1 CARTON12/18/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342012/18/2020
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-840
    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 SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Elliptical) Size22mm
    FlavorImprint Code G;1200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-840-717 in 1 CARTON12/18/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:62207-840-994200 in 1 BAG; Type 0: Not a Combination Product12/18/2020
    3NDC:62207-840-9310000 in 1 BOX; Type 0: Not a Combination Product10/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21342012/18/2020
    Labeler - Granules India Ltd (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Ltd918609236analysis(62207-839, 62207-840) , label(62207-839, 62207-840) , manufacture(62207-839, 62207-840) , pack(62207-839, 62207-840)
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