Maximum Strength

SPL v4

SPL

SPL Set ID 32d7a87a-fd67-4a84-8790-fc43ff30868d

Route

ORAL

Published

Effective Date 2022-11-17

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 Glycerin Povidone Water Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 250 Shape: oval Color: purple Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-17

Description

Simethicone 250 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Uses

relives 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 mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician

Drug Facts

Distributed By:

Rite Aid

30 Hunter Lane, Camp Hill, Pa 17011

Other Information

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

Inactive Ingredients

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Keep Out of Reach of Children

Active Ingredient (in Each Tablet)

Simethicone 250 mg

Structured Label Content

Uses

relives 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 mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician

Drug Facts

Distributed By: (Distributed by:)

Rite Aid

30 Hunter Lane, Camp Hill, Pa 17011

Other Information

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

Inactive Ingredients (Inactive ingredients)

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

Keep Out of Reach of Children (Keep out of reach of children)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Simethicone 250 mg

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", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "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": "relives 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 mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician", "Distributed by:": "Rite Aid 30 Hunter Lane, Camp Hill, Pa 17011", "Other Information": "• store at room temperature 59-86°F (15-30°C)", "Inactive ingredients": "D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide", "Questions or comments?": "1-888-333-9792", "Active Ingredient (in each tablet)": "Simethicone 250 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:48.257319 · Updated: 2026-03-14T23:05:48.377821