Label: GUAIFENESIN EXTENDED-RELEASE- guaifenesin tablet, multilayer, extended release

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

Drug Label Information

Updated November 15, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each extended-release tablet)

    Guaifenesin 600 mg

  • Purpose

    Expectorant

  • Uses

    • 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 a 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.

    If pregnant or breast-feeding, 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

    • Use as directed per healthcare professional.
    • 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.
    • children under 12 years of age: do not use
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    1-800-397-9228

  • SPL UNCLASSIFIED SECTION

    Gluten Free

  • How Supplied

    NDC 68094-048-61
    Unit Dose Packages of 100 Tablets (10×10) per Carton

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Perrigo
    Allegan, MI 49010

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

    LI1382 Rev. 06/22

  • PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton

    PrecisionDose™

    NDC 68094-048-61
    Unit Dose

    guaiFENesin
    Extended-Release
    Tablets,

    600 mg

    100 Tablets
    (10 x 10)

    (in each extended-release tablet)
    Guaifenesin 600 mg....Expectorant.

    Directions: do not crush, chew, or
    break tablet take with a full glass of water

    Unique Bi-Layer Tablet
    GLUTEN FREE

    USUAL DOSE: See Enclosed Drug Facts
    Store at 20-25°C (68-77°F)

    Keep out of reach of children.
    Hospital Use Only.

    LC1384
    R0

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN EXTENDED-RELEASE 
    guaifenesin tablet, multilayer, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-048(NDC:0113-2023)
    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 PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code L2X2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68094-048-6110 in 1 CARTON03/22/2023
    1NDC:68094-048-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07891203/22/2023
    Labeler - Precision Dose Inc. (035886746)
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