Topcare®

Topcare®
SPL v2
SPL
SPL Set ID 42c449cc-a450-1796-e063-6294a90a762a
Route
ORAL
Published
Effective Date 2025-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (180 mg)
Inactive Ingredients
Ammonia Ferrosoferric Oxide Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Isopropyl Alcohol Butyl Alcohol Peppermint Oil Propylene Glycol Shellac Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-17

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

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

Bloating

Pressure

Fullness & Gas

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO STVA0925

[email protected]     www.topcarebrand.com

PRODUCT OF INDIA

QUALITY GUARANTEED

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

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

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

• protect from light, heat, and moisture

Inactive Ingredients

ammonium hydroxide, black iron oxide, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, n-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan anhydrous, 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)

COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

Bloating

Pressure

Fullness & Gas

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO STVA0925

[email protected]     www.topcarebrand.com

PRODUCT OF INDIA

QUALITY GUARANTEED

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

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

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

• protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, black iron oxide, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, n-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan anhydrous, 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


Raw Label Data

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