Maximum Strength Gas Relief

SPL v2

SPL

SPL Set ID 79a9e0a3-9199-4397-ab29-b8a9c843cdf8

Route

ORAL

Published

Effective Date 2021-02-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (250 mg)

Inactive Ingredients

D&c Red No. 33 Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC31 Shape: capsule Color: purple Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-12-18

Description

Simethicone 250 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Directions

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Active Ingredient

Simethicone 250 mg

Other Information

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Package/label Principal Display Panel – Principal Display Panel

Maximum Strength Gas Relief

Simethicone 250 mg 60ct

NDC: 79903-020-22

Structured Label Content

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Anti-gas

Warnings

Stop use and ask a doctor if

condition persists

Directions

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Active Ingredient (Active ingredient)

Simethicone 250 mg

Other Information

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Package/label Principal Display Panel – Principal Display Panel (Package/Label Principal Display Panel – Principal Display Panel)

Maximum Strength Gas Relief

Simethicone 250 mg 60ct

NDC: 79903-020-22

Advanced Ingredient Data

[{"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating, pressure or fullness commonly referred to as gas", "Purpose": "Anti-gas", "Warnings": "Stop use and ask a doctor if condition persists", "Directions": "swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "Active ingredient": "Simethicone 250 mg", "Other Information": "store at room temperature 59°-86°F (15°-30°C)", "Inactive Ingredients": "D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink", "Questions or comments?": "Call toll free: 1-855-215-8180", "Package/Label Principal Display Panel – Principal Display Panel": "Maximum Strength Gas Relief Simethicone 250 mg 60ct NDC: 79903-020-22"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.783176 · Updated: 2026-03-14T23:05:18.894850