Maximum Strength

SPL v5

SPL

SPL Set ID f83b89c8-430a-444a-94a5-5ec492b8b812

Route

ORAL

Published

Effective Date 2021-12-27

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 Titanium Dioxide

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-12-27

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

Label

Carton

Section 42229-5

Distributed by:

RITE AID

30 Hunter Lane, Camp Hill, PA 17011

www.riteaid.com

Made in India

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask a doctor if condition persists

Warnings

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

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 Softgel)

Simethicone 250 mg

Structured Label Content

Uses

relives bloating, pressure or fullness commonly referred to as gas

Label

Carton

Section 42229-5 (42229-5)

Distributed by:

RITE AID

30 Hunter Lane, Camp Hill, PA 17011

www.riteaid.com

Made in India

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition persists

Purpose

Anti-gas

Warnings

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

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

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

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", "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": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relives bloating, pressure or fullness commonly referred to as gas", "42229-5": "Distributed by: RITE AID 30 Hunter Lane, Camp Hill, PA 17011 www.riteaid.com Made in India", "50565-1": "Keep out of reach of children", "50566-9": "Stop use and ask a doctor if condition persists", "Purpose": "Anti-gas", "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", "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 softgel)": "Simethicone 250 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.073965 · Updated: 2026-03-14T23:06:36.654428