maximum strength gas relief softgel

SPL v4

SPL

SPL Set ID 57043cae-a8db-4eff-835c-5995e8aea924

Route

oral

Published

Effective Date 2023-03-13

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 2023-02-20

Purpose

Anti-gas

Description

Simethicone 250 mg

Medication Information

Warnings

Stop use and ask a doctor if condition persists.

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

Uses

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

Purpose

Anti-gas

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

Description

Simethicone 250 mg

Section 42229-5

LEADER_™

Relieves:

Bloating

Pressure

Fullness

COMPARE TO PHAZYME^® MAXIMUM STRENGTH active ingredient*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

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

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Product of United Arab Emirates

Section 50565-1

Keep out of reach of children.

Packaging

Drug Facts

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Simethicone 250 mg

Structured Label Content

Warnings

Stop use and ask a doctor if condition persists.

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

Uses

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

Purpose

Anti-gas

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

Section 42229-5 (42229-5)

LEADER_™

Relieves:

Bloating

Pressure

Fullness

COMPARE TO PHAZYME^® MAXIMUM STRENGTH active ingredient*

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

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

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Product of United Arab Emirates

Section 50565-1 (50565-1)

Keep out of reach of children.

Packaging

Drug Facts

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": "LEADER ™ Relieves: Bloating Pressure Fullness COMPARE TO PHAZYME ® MAXIMUM STRENGTH active ingredient* 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme ® Maximum Strength. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners. Product of United Arab Emirates", "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 #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: 2026-02-15T12:02:41.537654 · Updated: 2026-03-14T23:02:23.126471