Label: GUAIFENESIN tablet, extended release

  • NDC Code(s): 51660-566-21, 51660-566-41, 51660-567-54, 51660-567-58, view more
    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 December 15, 2022

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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.

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

    †Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

  • 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.

  • Package/Label Principal Display Panel

    600 mg 20's
  • Package/Label Principal Display Panel

    600mg 40's
  • Principal Display Panel

    1200mg 14 count
  • Principal Display Panel

    1200mg 28 count
  • Principal Display Panel

    1200 mg 56 count
  • 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
    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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