Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID b114b07e-6822-465a-9e74-2a741ccb19f7

Route

ORAL

Published

Effective Date 2025-10-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dimethicone (180 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC3 Shape: capsule Color: orange Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-31

Description

Simethicone 180 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 180 mg

Use

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

Directions

swallow one or two softgels as symptoms occur
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Package Label

CVS Ultra Strength Gas Relief

Other Information

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, water

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Phazyme^® Ultra Strength active ingredient*

Ultra Strength

GAS RELIEF

Simethicone, 180 mg

Anti-gas

Fast Relief of: Pressure, Bloating, & Discomfort

SOFTGELS

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Stop Use and Ask A Doctor If

condition persists.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Use

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

Purpose

Antigas

Directions

swallow one or two softgels as symptoms occur
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Package Label

CVS Ultra Strength Gas Relief

Other Information (Other information)

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, water

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Phazyme^® Ultra Strength active ingredient*

Ultra Strength

GAS RELIEF

Simethicone, 180 mg

Anti-gas

Fast Relief of: Pressure, Bloating, & Discomfort

SOFTGELS

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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", "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)

{"Use": "relieves bloating, pressure, or fullness commonly referred to as gas", "Purpose": "Antigas", "Directions": "swallow one or two softgels as symptoms occur do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "Package Label": "CVS Ultra Strength Gas Relief", "Other information": "store between 15-30ºC (59-86ºF) protect from heat and moisture", "Inactive ingredients": "FD&C yellow #6, gelatin, glycerin, water", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "Compare to Phazyme ® Ultra Strength active ingredient* Ultra Strength GAS RELIEF Simethicone, 180 mg Anti-gas Fast Relief of: Pressure, Bloating, & Discomfort SOFTGELS *This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895", "Stop use and ask a doctor if": "condition persists.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.620767 · Updated: 2026-03-14T23:13:06.603726