Label: E-Z-GAS II- antacid/antiflatulent granule, effervescent

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

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  • DESCRIPTION

    Drug Facts

    Active Ingredients (in each packet)Purpose
    Citric Acid 1.53 g Antacid
    Simethicone 0.04 g Antiflatulent
    Sodium Bicarbonate 2.21 g Antacid
  • PURPOSE

    Uses

    • relieves
      - heartburn           - acid indigestion
      - sour stomach    - upset stomach
    • relieves gas associated with these symptoms
  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use

    • In cases of known or suspected esophageal obstruction.
    • To dislodge foreign bodies.
    • More than the maximum recommended dosage in 24-hour period.
    • the maximum dosage of this product for more than two weeks, except under the advice and supervision of a physician.
  • ASK DOCTOR

    Ask a doctor before use

    • if you are taking a prescription drug. Antacids may interact with certain prescription drugs.
    • If you have a sodium restricted diet.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose seek medical help or contact a poison center immediately.

  • ACTIVE INGREDIENT

    Once package is opened, discard unused portion.

  • DOSAGE & ADMINISTRATION

    Directions

     Recommended doseMaximum
    recommended dose
    Adults
    (under 60 years)
    One packet every 6 hours or as directed by physicianNot to exceed 4 packets in 24 hours
    Adults
    (60 years and older)
    One packet every 8 hours or as directed by physicianNot to exceed 3 packets in 24 hours
    Children
    (6 to 12 years)
    One packet every 8 hours or as directed by physicianNot to exceed 3 packets in 24 hours
    Children
    Under 6 years
    Consult physicianConsult physician
  • HOW SUPPLIED

    Other information

    • Store at controlled room temperature 15⁰ - 30⁰ C (59⁰ - 86⁰F).
    • Protect from moisture.
    • Sodium content: approximately 26 mEq (600 mg) per dose.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Maltodextrin, natural orange flavor, sodium saccharin.

  • QUESTIONS

    Questions? 1-516-333-8230 or 1-800-5444624

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    E-Z-Gas II
    NDC: 10361-793-01

    e-z-gas-II-carton
  • PRINCIPAL DISPLAY PANEL

    E-Z-Gas II Label
    NDC: 10361-793-01

    e-z-gas-II-foil
  • INGREDIENTS AND APPEARANCE
    E-Z-GAS  II
    antacid/antiflatulent granule, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10361-793
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID380 mg  in 1 g
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) SODIUM BICARBONATE550 mg  in 1 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10361-793-0150 in 1 BOX05/01/1986
    14 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00105/01/1986
    Labeler - E-Z-EM, INC. (002041226)
    Registrant - E-Z-EM, INC. (002041226)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tower Laboratories Ltd001587203MANUFACTURE(10361-793)