E-z-gas Granule, Effervescent
FDA Label NDC 10361-793

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by E-z-em, Inc. for the product E-z-gas (NDC 10361-793). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - keep out of reach of children, otc - active ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Otc - Purpose

→ Warnings

→ Otc - Do Not Use

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Otc - Active Ingredient

→ Dosage & Administration

→ How Supplied

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

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

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 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