drug facts

drug facts

SPL v4

SPL

SPL Set ID fa85df3f-243d-470b-ad28-82512e05fbbe

Route

oral

Published

Effective Date 2025-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

dimethicone (125 mg)

Inactive Ingredients

d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 gelatin glycerin peppermint oil water sorbitan sorbitol titanium dioxide mannitol

Identifiers & Packaging

Pill Appearance

Imprint: PO Shape: oval Color: green Size: 9 mm Score: 1

Marketing Status

otc monograph drug active Since 2023-03-31

Purpose

Antigas

Description

Simethicone 125 mg

Medication Information

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Purpose

Antigas

Directions

adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

store between 20-25°C (68-77°F)
do not refrigerate
protect from light, heat, and moisture

Inactive Ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Description

Simethicone 125 mg

Principal Display Panel

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

EXTRA STRENGTH

Gas Relief

Simethicone 125 mg

ANTI-GAS

Relieves Gas Symptoms

Fast fast relief of:

Pressure
Bloating
Discomfort

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Haleon group of companies, distributor of Gas- X® Extra Strength.

Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphis, TN 38141

www.fosterand thrive.com

Product Label

FOSTER & THRIVE Extra Strength Gas Relief

Questions Or Comments?

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Purpose

Antigas

Directions

adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information (Other information)

store between 20-25°C (68-77°F)
do not refrigerate
protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

EXTRA STRENGTH

Gas Relief

Simethicone 125 mg

ANTI-GAS

Relieves Gas Symptoms

Fast fast relief of:

Pressure
Bloating
Discomfort

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Haleon group of companies, distributor of Gas- X® Extra Strength.

Distributed by: McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphis, TN 38141

www.fosterand thrive.com

Product Label

FOSTER & THRIVE Extra Strength Gas Relief

Questions Or Comments? (Questions or comments?)

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 125 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of pressure, bloating, and fullness commonly referred to as gas", "Purpose": "Antigas", "Directions": "adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician", "Product Label": "FOSTER & THRIVE Extra Strength Gas Relief", "Other information": "store between 20-25°C (68-77°F) do not refrigerate protect from light, heat, and moisture", "Inactive ingredients": "D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide", "Questions or comments?": "Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "Principal Display Panel": "COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT* EXTRA STRENGTH Gas Relief Simethicone 125 mg ANTI-GAS Relieves Gas Symptoms Fast fast relief of: Pressure Bloating Discomfort SOFTGELS TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. *This product is not manufactured or distributed by Haleon group of companies, distributor of Gas- X® Extra Strength. Distributed by: McKesson Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141 www.fosterand thrive.com", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each softgel)": "Simethicone 125 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:08.582499 · Updated: 2026-03-14T23:10:32.676275