Maximum Strength Gas Relief

SPL v1

SPL

SPL Set ID 9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763

Route

ORAL

Published

Effective Date 2019-03-22

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 FINAL Active Since 2019-03-25

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 – Drug Facts

Package/label Principal Display Panel – Principal Display Panel

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 – Drug Facts (Package/Label Principal Display Panel – Drug Facts)

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

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": ""}]

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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:47.057523 · Updated: 2026-03-14T22:55:27.684543