Extra Strength Gas Relief

SPL v7

SPL

SPL Set ID b715f2d5-df52-4406-ac63-aee0c9495661

Route

ORAL

Published

Effective Date 2020-03-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Peppermint Oil Sorbitan Sorbitol Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance

Imprint: 152 Shape: oval Color: green Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-03-16

Description

Simethicone 125mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125mg

Use

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 physician

Other Information

store at controlled room temperature 20-25ºC (68-77ºF)
protect from light, heat, and moisture

Inactive Ingredients

FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Compare to the active ingredient

in Extra Strength Gas-X®†

Extra Strength Gas Relief

SIMETHICONE 125 MG / ANTIGAS

RELIEVES GAS FAST

PRESSURE

BLOATING

DISCOMFORT

†This product is not manufactured or distributed by GlaxoSmithKline,

owner of the registered trademark Extra Strength Gas-X®

Active Ingredient (in Each Softgel)

Simethicone 125mg

Structured Label Content

Use

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 at controlled room temperature 20-25ºC (68-77ºF)
protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient

in Extra Strength Gas-X®†

Extra Strength Gas Relief

SIMETHICONE 125 MG / ANTIGAS

RELIEVES GAS FAST

PRESSURE

BLOATING

DISCOMFORT

†This product is not manufactured or distributed by GlaxoSmithKline,

owner of the registered trademark Extra Strength Gas-X®

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

Simethicone 125mg

Advanced Ingredient Data

[{"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": "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": "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "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 at controlled room temperature 20-25ºC (68-77ºF) protect from light, heat, and moisture", "Inactive ingredients": " FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide", "Questions or comments?": "1-888-333-9792", "PRINCIPAL DISPLAY PANEL": "Compare to the active ingredient in Extra Strength Gas-X®† Extra Strength Gas Relief SIMETHICONE 125 MG / ANTIGAS RELIEVES GAS FAST PRESSURE BLOATING DISCOMFORT †This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Extra Strength Gas-X®", "Active ingredient (in each softgel)": "Simethicone 125mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:45.853124 · Updated: 2026-03-14T23:05:41.137982