drug facts

drug facts

SPL v8

SPL

SPL Set ID 4ff77b4c-9616-4341-9bf8-eca301345a5f

Route

oral

Published

Effective Date 2025-12-17

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 2023-11-30

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: 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

Fast Relief of: Pressure, Bloating, Discomfort

SOFTGELS

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

CVS Extra Strength Gas Relief

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM 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: 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 (Principal display panel)

Compare to Gas-X® Extra Strength active ingredient*

Extra Strength

GAS RELIEF

Simethicone 125 mg

Anti-gas

Fast Relief of: Pressure, Bloating, Discomfort

SOFTGELS

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

CVS Extra Strength Gas Relief

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM 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

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the relief of pressure, bloating, and fullness commonly referred to as gas.", "Purpose": "Antigas", "Directions": "adults: 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": "CVS 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 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal display panel": "Compare to Gas-X® Extra Strength active ingredient* Extra Strength GAS RELIEF Simethicone 125 mg Anti-gas Fast Relief of: Pressure, Bloating, Discomfort SOFTGELS *This product is not manufactured or distributed by Haleon group of companies, distributor of Gas-X ® Extra Strength. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895", "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: 2026-02-15T12:06:55.308431 · Updated: 2026-03-14T23:11:33.591824