Label: GUAIFENESIN tablet, extended release

  • NDC Code(s): 51660-566-21, 51660-566-41, 51660-566-68, 51660-567-54, view more
    51660-567-58, 51660-567-86
  • Packager: Ohm Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 12, 2026

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  • Active ingredient

    (in each extended-release tablet)

    Guaifenesin, USP

  • Purpose

    Expectorant

  • 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).

  • Uses

    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bronchial 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 serious illness.

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

  • Directions

    • 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 over 12 years of age and over: one or two 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.

    Other information

    • store between 20-25°C (68-77°F)
    • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
  • Inactive Ingredients

    colloidal silicon dioxide, FD&C blue # 2, aluminum lake, hypromellose, magnesium stearate, povidone.

    Questions

    call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

  • SPL UNCLASSIFIED SECTION

    Keep the carton. It contains important information. See end panel for expiration date.

    †OHM and OHM Logo are trademarks of Ohm Laboratories, Inc. All other trademarks are the property of their respective owners.

    Distributed by:
    Ohm Laboratories Inc.
    New Brunswick, NJ 08901


    PRODUCT OF INDIA


    R0425

    CODE No.: PB/DRUGS/1809-0SP

  • Package/Label Principal Display Panel - Guaifenesin ER Tablets, 600 mg

    spl-guaifenesin-ohm

  • Principal Display Panel - Guaifenesin ER Tablets, 1200 mg

    spl-guaifenesin-ohm2

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-566
    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)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (blue/white mottled) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code RH;98
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-566-4140 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
    2NDC:51660-566-2120 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
    3NDC:51660-566-6868 in 1 CARTON; Type 0: Not a Combination Product01/17/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20925404/01/2022
    GUAIFENESIN 
    guaifenesin tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-567
    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)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    Colorwhite (blue/white mottled) Scoreno score
    ShapeOVALSize16mm
    FlavorImprint Code RH;99
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51660-567-5414 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
    2NDC:51660-567-8628 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
    3NDC:51660-567-5856 in 1 CARTON; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20925404/01/2022
    Labeler - Ohm Laboratories, Inc. (184769029)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories, Inc.184769029manufacture(51660-566, 51660-567) , analysis(51660-566, 51660-567) , pack(51660-566, 51660-567)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650456002manufacture(51660-566, 51660-567)
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