FDA Label for E-z-gas II

View Indications, Usage & Precautions

E-z-gas II Product Label

The following document was submitted to the FDA by the labeler of this product E-z-em, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

Otc - Purpose



Uses

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

Warnings



Warnings


Otc - 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.

Otc - 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.

Otc - 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.


Otc - 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.


Otc - Questions



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


Package Label.Principal Display Panel



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

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


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