Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 69256-135

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter, Llc for the product Extra Strength Gas Relief (NDC 69256-135). 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 active ingredient(in each tablet), purpose, use(s), warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(in Each Tablet)

→ Purpose

→ Use(s)

→ Warnings

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient(In Each Tablet)

Simethicone 125 mg

Purpose

Anti-gas

Use(S)

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a poison control center immediately.

Directions

adults and children 12 years and older: chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.

Other Information

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40°C (104°F)

Inactive Ingredients

D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose.