Topcare®

Topcare®
SPL v2
SPL
SPL Set ID 2ea0eb22-f679-d136-e063-6294a90a1dfe
Route
ORAL
Published
Effective Date 2025-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Ammonia Ferrosoferric Oxide D&c Yellow No. 10 Fd&c Blue No. 1 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 2025-08-01

Description

Simethicone 125 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of

  • Pressure, bloating, and fullness commonly referred to as gas
Section 42229-5

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

  • Bloating
  • Pressure
  • Fullness & Gas

KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO STVA0425

[email protected]   www.topcarebrand.com

PRODUCT OF INDIA

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Gas-X®.

QUALITY GUARANTEED

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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.

Packaging

Directions
  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Drug Facts

Questions?

Call 1-888-423-0139

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, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Active Ingredient (in Each Softgel)

Simethicone 125 mg


Structured Label Content

Uses

for the relief of

  • Pressure, bloating, and fullness commonly referred to as gas
Section 42229-5 (42229-5)

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

  • Bloating
  • Pressure
  • Fullness & Gas

KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143 ©TOPCO STVA0425

[email protected]   www.topcarebrand.com

PRODUCT OF INDIA

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Gas-X®.

QUALITY GUARANTEED

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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

Packaging

Directions
  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Drug Facts

Questions?

Call 1-888-423-0139

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, D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan solution, titanium dioxide

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

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)