E-Z-GAS II: Package Insert and Label Information

E-Z-GAS II- anhydrous citric acid, sodium bicarbonate, dimethicone and silicon dioxide granule, effervescent
E-Z-EM, INC.

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.

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

Uses

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

Warnings

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 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. In case of overdose seek medical help or contact a poison center immediately.

Once package is opened, discard unused portion.

Directions

Recommended dose Maximum
recommended dose
Adults
(under 60 years)
One packet every 6 hours or as directed by physician Not to exceed 4 packets in 24 hours
Adults
(60 years and older)
One packet every 8 hours or as directed by physician Not to exceed 3 packets in 24 hours
Children
(6 to 12 years)
One packet every 8 hours or as directed by physician Not to exceed 3 packets in 24 hours
Children
Under 6 years
Consult physician Consult physician

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 ingredients

Maltodextrin, natural orange flavor, sodium saccharin.

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

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

e-z-gas-II-carton
(click image for full-size original)

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

e-z-gas-II-foil
(click image for full-size original)
E-Z-GAS II
antacid/antiflatulent granule, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10361-793
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANHYDROUS CITRIC ACID (Anhydrous Citric Acid) ANHYDROUS CITRIC ACID 380 mg in 1 g
SODIUM BICARBONATE (Bicarbonate Ion) SODIUM BICARBONATE 550 mg in 1 g
DIMETHICONE (Dimethicone) DIMETHICONE 10 mg in 1 g
SILICON DIOXIDE (Silicon Dioxide) SILICON DIOXIDE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Maltodextrin
Saccharin Sodium
Product Characteristics
Color WHITE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10361-793-01 50 POUCH in 1 BOX contains a POUCH
1 4 g in 1 POUCH This package is contained within the BOX (10361-793-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 05/01/1986
Labeler — E-Z-EM, INC. (002041226)
Registrant — E-Z-EM, INC. (002041226)
Establishment
Name Address ID/FEI Operations
Tower Laboratories Ltd 001587203 MANUFACTURE (10361-793)

Revised: 11/2022 E-Z-EM, INC.

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