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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Updated November 1, 2022

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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 finalpart33105/01/1986
    Labeler - E-Z-EM, INC. (002041226)
    Registrant - E-Z-EM, INC. (002041226)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tower Laboratories Ltd001587203MANUFACTURE(10361-793)
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