Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 33700cc7-48bc-4174-9f9a-36a50b4c91f3

Route

ORAL

Published

Effective Date 2025-10-07

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 Fd&c Red No. 40

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

Uses

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

Directions

swalow one or two softgels as needed after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Product Label

EQUALINE Ultra Strength GasRelief

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

Call toll free 1-855-423-2630

Principal Display Panel

*Compare to Phazyme® Ultra Strength active ingredient†

Ultra Strength

gas relief

simethicone 180 mg

(Antigas)

Fast relief of:

gas
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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908

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

Uses

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

Purpose

Antigas

Directions

swalow one or two softgels as needed after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Product Label

EQUALINE Ultra Strength GasRelief

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free 1-855-423-2630

Principal Display Panel

*Compare to Phazyme® Ultra Strength active ingredient†

Ultra Strength

gas relief

simethicone 180 mg

(Antigas)

Fast relief of:

gas
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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908

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": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating, pressure, or fullness commonly referred to as gas", "Purpose": "Antigas", "Directions": "swalow one or two softgels as needed after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "Product Label": "EQUALINE Ultra Strength GasRelief", "Other information": "store at 15º-30ºC (59º-86ºF) protect from heat and moisture", "Inactive ingredients": "FD&C yellow #6, gelatin, glycerin, purified water", "Questions or comments?": "Call toll free 1-855-423-2630", "Principal Display Panel": "*Compare to Phazyme® Ultra Strength active ingredient† Ultra Strength gas relief simethicone 180 mg (Antigas) Fast relief of: gas 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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY UNFI PROVIDENCE, RI 02908", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:40.593362 · Updated: 2026-03-14T23:12:56.390264