Quality Choice®

SPL v1

SPL

SPL Set ID 462fdb9a-d685-4772-9233-6c43db9382cc

Route

ORAL

Published

Effective Date 2024-08-16

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 2024-08-16

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 Maximum Strength Phazyme^®

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

PRODUCT OF UNITED ARAB EMIRATES

QC 100% SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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 heat, humidity and light

Inactive Ingredients

D&C red no.33, edible ink, FD&C blue no.1, gelatin, glycerin, purified water

Questions Or Comments?

1-888-577-8033

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 Maximum Strength Phazyme^®

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

PRODUCT OF UNITED ARAB EMIRATES

QC 100% SATISFACTION GUARANTEED

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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 heat, humidity and light

Inactive Ingredients (Inactive ingredients)

D&C red no.33, edible ink, FD&C blue no.1, gelatin, glycerin, purified water

Questions Or Comments? (Questions or comments?)

1-888-577-8033

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 Maximum Strength Phazyme ® READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of PHAZYME ® . PRODUCT OF UNITED ARAB EMIRATES QC 100% SATISFACTION GUARANTEED Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362", "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 heat, humidity and light", "Inactive ingredients": "D&C red no.33, edible ink, FD&C blue no.1, gelatin, glycerin, purified water", "Questions or comments?": "1-888-577-8033 ", "Active ingredient (in each softgel)": "Simethicone 250 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:29.076599 · Updated: 2026-03-14T23:03:32.552873