Label: GUAIFENESIN 600 MG tablet
GUAIFENESIN 1200 MG tablet

  • NDC Code(s): 25000-041-12, 25000-041-75, 25000-042-01, 25000-042-12, view more
    25000-042-55
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 28, 2023

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  • OTC - ACTIVE INGREDIENT SECTION

    For 600 mg:           
    Active ingredient (in each extended-release tablet)

    Guaifenesin, USP 600 mg


    For 1200 mg:
    Active ingredient (in each extended-release tablet)

    Guaifenesin, USP 1200 mg

  • OTC - PURPOSE SECTION

    Purpose

    Expectorant


  • INDICATIONS & USAGE SECTION

    Uses

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

  • WARNINGS SECTION

  • OTC - DO NOT USE SECTION

    Do not use

    • for children under 12 years of age

  • OTC - ASK DOCTOR SECTION

    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)

  • OTC - STOP USE SECTION

    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.
  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • DOSAGE & ADMINISTRATION SECTION

    Directions

    For 600 mg

    • do not crush, chew, or break extended - release tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 or 2 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours.
    • children under 12 years of age: do not use


    For 1200 mg

    • do not crush, chew, or break extended - release tablet
    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • adults and children 12 years of age and over: 1 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours.
    • children under 12 years of age: do not use


  • STORAGE AND HANDLING SECTION

    Other information

    • store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT SECTION

    Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

  • OTC - QUESTIONS SECTION

    Questions or comments?

    Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
    You may also report side effects to this phone number.


    Manufactured for:
    Time-Cap Labs, Inc.
    7 Michael Avenue,
    Farmingdale,
    NY 11735, USA


    Manufactured by:
    Marksans Pharma Ltd.
    Plot No. L-82, L-83
    Verna Indl. Estate
    Verna, Goa-403722, India 


  • PRINCIPAL DISPLAY PANEL

    NDC: 25000-042-55

    Guaifenesin Extended-Release Tablets 600 mg

    20's count (2 x 10's blister) Carton


    guaifenesin-600mg-blister-ifc20s


    NDC: 25000-042-01

    Guaifenesin Extended-Release Tablets 600 mg

    20's count Bottle Label


    guaifenesin-600mg-bottle-label-20s


    NDC: 25000-042-01

    Guaifenesin Extended-Release Tablets 600 mg

    20's count Bottle Carton


    guaifenesin-600mg-bottle-ifc-20s


    NDC: 25000-042-12

    Guaifenesin Extended-Release Tablets 600 mg

    500's count Bottle Label


    guaifenesin-600mg-bottle-label-500s


    NDC: 25000-041-75

    Guaifenesin Extended-Release Tablets 1200 mg

    12's count (2 x 6's blister) Carton


    guaifenesin-1200mg-blister-ifc-12s


    NDC: 25000-041-12

    Guaifenesin Extended-Release Tablets 1200 mg

    500's count Bottle Label


    guaifenesin-1200mg-bottle-label-500s



  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 600 MG 
    guaifenesin 600 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-042
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    Product Characteristics
    ColorWHITE (Blue and White) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-042-552 in 1 CARTON08/23/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:25000-042-011 in 1 CARTON08/23/2023
    220 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-042-12500 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21778008/23/2023
    GUAIFENESIN 1200 MG 
    guaifenesin 1200 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-041
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN1200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    Product Characteristics
    ColorWHITE (Blue and White) Scoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code 41
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-041-752 in 1 CARTON08/23/2023
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:25000-041-12500 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21778008/23/2023
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-041, 25000-042)
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