cvs

cvs
SPL v3
SPL
SPL Set ID 2911cac8-45ec-1294-e063-6294a90a4a74
Route
oral
Published
Effective Date 2025-01-31
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 isopropyl alcohol light mineral oil medium-chain triglycerides water soybean lecithin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-31

Purpose

Anti-gas

Description

Simethicone 250 mg


Medication Information

Warnings

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

Uses

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

Purpose

Anti-gas

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 2 softgels per 24 hours except under the advice and supervision of a physician

Other Information

• store at room temperature between 20-25°C (68-77°F)

• protect from light, heat and moisture

Inactive Ingredients

D&C Red No. 33, edible ink, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, purified water, soy lecithin

Description

Simethicone 250 mg

Section 42229-5

Compare to the active ingredient in Gas-X® Maximum Strength Softgels*

Fast relief of:

• Bloating

• Pressure

• Fullness

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

Product of United Arab Emirates

V-39102

100% money back guaranteed.

CVS.com/returnpolicy

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

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

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Simethicone 250 mg


Structured Label Content

Warnings

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

Uses

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

Purpose

Anti-gas

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 2 softgels per 24 hours except under the advice and supervision of a physician

Other Information (Other information)

• store at room temperature between 20-25°C (68-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

D&C Red No. 33, edible ink, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, purified water, soy lecithin

Section 42229-5 (42229-5)

Compare to the active ingredient in Gas-X® Maximum Strength Softgels*

Fast relief of:

• Bloating

• Pressure

• Fullness

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

Product of United Arab Emirates

V-39102

100% money back guaranteed.

CVS.com/returnpolicy

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

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.

Packaging

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


Raw Label Data

All Sections (JSON)