extra strength gas relief

SPL v5

SPL

SPL Set ID 362eaf8b-0aea-4a99-9266-83992bcf444e

Route

oral

Published

Effective Date 2021-12-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (125 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: 152 Shape: oval Color: green Size: 10 mm Score: 1

Marketing Status

otc monograph drug active Since 2021-12-22

Purpose

Antigas

Description

Simethicone 125 mg

Medication Information

Warnings

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 at controlled room temperature 20-25°C (68-77°F)

• protect from light, heat, and moisture

Inactive Ingredients

FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Description

Simethicone 125 mg

Carton

Section 50565-1

Keep out of reach of children

Drug Facts

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

Warnings

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 at controlled room temperature 20-25°C (68-77°F)

• protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Carton

Section 50565-1 (50565-1)

Keep out of reach of children

Drug Facts

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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

Simethicone 125 mg

Advanced Ingredient Data

[{"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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", "50565-1": "Keep out of reach of children", "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 20-25°C (68-77°F) • protect from light, heat, and moisture", "Inactive ingredients": "FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide", "Questions or comments?": "1-888-333-9792", "Active Ingredient (in each softgel)": "Simethicone 125 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:09.216114 · Updated: 2026-03-14T23:06:32.989437