Gas Relief Ultra Strength

SPL v4

SPL

SPL Set ID b9a4c876-722b-4d6c-807f-005ccf5df320

Route

ORAL

Published

Effective Date 2025-01-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (180 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Peppermint Oil Water Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 792 Shape: oval Color: orange Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Simethicone 180 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 180 mg

Uses

for the relief of pressure and bloating commonly referred to as gas

Section 42229-5

TopCare _®health

COMPARE TO GAS-X^® ULTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

• Bloating

• Pressure

• Fullness & Gas

DISTRIBUTED BY TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, I. 60007

©TOPCO STVA0523

[email protected] www.topcarebrand.com

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

QUALITY GUARANTEED

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

Section 50565-1

Keep out of reach of children.

Warnings

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

Packaging

Directions

adults and children 12 years or older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Drug Facts

Other Information

store between 20-25°C (68-77°F)
protect from heat and moisture

Inactive Ingredients

edible printing ink, FD&C yellow no. 6, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions Or Comments?

Call 1-888-423-0139

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Uses

for the relief of pressure and bloating commonly referred to as gas

Section 42229-5 (42229-5)

TopCare _®health

COMPARE TO GAS-X^® ULTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

• Bloating

• Pressure

• Fullness & Gas

DISTRIBUTED BY TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, I. 60007

©TOPCO STVA0523

[email protected] www.topcarebrand.com

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

QUALITY GUARANTEED

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antigas

Warnings

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

Packaging

Directions

adults and children 12 years or older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician

Drug Facts

Other Information (Other information)

store between 20-25°C (68-77°F)
protect from heat and moisture

Inactive Ingredients (Inactive ingredients)

edible printing ink, FD&C yellow no. 6, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-888-423-0139

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

Simethicone 180 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "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": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of pressure and bloating commonly referred to as gas", "42229-5": "TopCare ® health COMPARE TO GAS-X ® ULTRA STRENGTH ACTIVE INGREDIENT* FAST RELIEF OF: • Bloating • Pressure • Fullness & Gas DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, I. 60007 ©TOPCO STVA0523 topcare@topco.com www.topcarebrand.com *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X ® . QUALITY GUARANTEED TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION", "50565-1": "Keep out of reach of children.", "Purpose": "Antigas", "Warnings": "If pregnant or breast-feeding, ask a health professional before use.", "Directions": "adults and children 12 years or older: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician", "Other information": "store between 20-25°C (68-77°F) protect from heat and moisture", "Inactive ingredients": "edible printing ink, FD&C yellow no. 6, gelatin, glycerin, peppermint oil, purified water, titanium dioxide", "Questions or comments?": "Call 1-888-423-0139", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:14.423461 · Updated: 2026-03-14T23:06:44.003626