Maximum Strength Gas Relief Softgel

SPL v4

SPL

SPL Set ID de059bd9-40de-432d-9370-5d1e53bd89ac

Route

ORAL

Published

Effective Date 2024-12-31

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-11-01

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

Section 42229-5

Compare to the active ingredient in Gas-X^® Maximum Strength Softgels*

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X^® Maximum Strength Softgels.

Compare to the active ingredient in PHAZYME^® Maximum Strength*

Fast relief of:

• Bloating

• Pressure

• Fullness

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

TAMPER EVIDENT: DO NOT USE IF THE IMPRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING.

*This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of PHAZYME^®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy CVS.com^®

1-800-SHOP CVS

Product of United Arab Emirates.

V-39102

Section 50565-1

Keep out of reach of children.

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• Swallow one or two softgels as symptoms occur

• do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Drug Facts

Other Information

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

• protect from light, heat and moisture

Inactive Ingredients

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

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel)

Simethicone 250 mg

Structured Label Content

Uses

• relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5 (42229-5)

Compare to the active ingredient in Gas-X^® Maximum Strength Softgels*

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X^® Maximum Strength Softgels.

Compare to the active ingredient in PHAZYME^® Maximum Strength*

Fast relief of:

• Bloating

• Pressure

• Fullness

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

TAMPER EVIDENT: DO NOT USE IF THE IMPRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING.

*This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of PHAZYME^®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy CVS.com^®

1-800-SHOP CVS

Product of United Arab Emirates.

V-39102

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-gas

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• Swallow one or two softgels as symptoms occur

• do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Drug Facts

Other Information (Other information)

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

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am-4pm EST

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

Simethicone 250 mg

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", "42229-5": "Compare to the active ingredient in Gas-X ® Maximum Strength Softgels* *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X ® Maximum Strength Softgels. Compare to the active ingredient in PHAZYME ® Maximum Strength* Fast relief of: • Bloating • Pressure • Fullness READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION. TAMPER EVIDENT: DO NOT USE IF THE IMPRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING. *This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of PHAZYME ® . Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2022 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Product of United Arab Emirates. V-39102", "50565-1": "Keep out of reach of children.", "Purpose": "Anti-gas", "Warnings": "Stop use and ask a doctor if condition persists. If pregnant or breast-feeding , ask a health professional before use.", "Directions": "• Swallow one or two softgels as symptoms occur • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician", "Other information": "• store at room temperature 20-25°C (68-77°F) • protect from light, heat and moisture", "Inactive ingredients": "D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water", "Questions or comments?": "1-888-577-8033 Monday-Friday 8am-4pm EST", "Active ingredient (in each softgel)": "Simethicone 250 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.432849 · Updated: 2026-03-14T23:06:44.003626