Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 5e2b25a0-eddf-4d58-927f-bc72c0a92c88

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 2019-09-30

Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

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

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 physican

Product Label

CAREONE Extra Strength Gas Relief

Other Information

store between 20-25ºC (68-77ºF)
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 the active ingredient in Gas-X® Extra Strength†

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg Antigas

FAST RELIEF OF:

PRESSURE,

BLOATING

DISCOMFORT

SOFTGELS

**This product is not manufactured or distributed GSK Comsumer Healthcare, distributor of Gas-X® Extra Strength.

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.

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

If Pregnant of 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 physican

Product Label

CAREONE Extra Strength Gas Relief

Other Information (Other information)

store between 20-25ºC (68-77ºF)
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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Gas-X® Extra Strength†

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg Antigas

FAST RELIEF OF:

PRESSURE,

BLOATING

DISCOMFORT

SOFTGELS

**This product is not manufactured or distributed GSK Comsumer Healthcare, distributor of Gas-X® Extra Strength.

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.

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 • 1-877-846-9949

If Pregnant of Breast Feeding, (If pregnant of 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 : 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 physican", "Product Label": "CAREONE Extra Strength Gas Relief", "Other information": "store between 20-25ºC (68-77ºF) 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 the active ingredient in Gas-X® Extra Strength† EXTRA STRENGTH GAS RELIEF Simethicone 125 mg Antigas FAST RELIEF OF: PRESSURE, BLOATING DISCOMFORT SOFTGELS **This product is not manufactured or distributed GSK Comsumer Healthcare, distributor of Gas-X® Extra Strength. 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. DISTRIBUTED BY FOODHOLD U.S.A., LLC LANDOVER, MD 20785 • 1-877-846-9949", "If pregnant of breast-feeding,": "ask a health professional before use.", "Active ingredient (in each softgel)": "Simethicone 125 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:17.935606 · Updated: 2026-03-14T23:10:33.744870