Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID 8927d9eb-65b2-40f3-846c-dc9cd2884dea

Route

ORAL

Published

Effective Date 2024-05-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dimethicone (180 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin

Identifiers & Packaging

Pill Appearance

Imprint: 05A Shape: oval Color: orange Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-09-30

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

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

SIGNATURE CARE Ultra Strength Gas Relief

Other Information

store between 15-30°C (59-86°F)
protect from heat and moisture

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin

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

antiflatulent (Antigas

Fast Relief of:

Gas
Pressure
Bloating
Discomfort

SOFTGELS

†This product is not manufactured or distributed by C.B. Fleet Company, 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

BETTER LIBING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsllc.com

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

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

SIGNATURE CARE Ultra Strength Gas Relief

Other Information (Other information)

store between 15-30°C (59-86°F)
protect from heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin

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

antiflatulent (Antigas

Fast Relief of:

Gas
Pressure
Bloating
Discomfort

SOFTGELS

†This product is not manufactured or distributed by C.B. Fleet Company, 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

BETTER LIBING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsllc.com

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

Raw Label Data

All Sections (JSON)

{"Uses": "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": "SIGNATURE CARE Ultra Strength Gas Relief", "Other information": "store between 15-30°C (59-86°F) protect from heat and moisture", "Inactive ingredients": "FD&C red #40, FD&C yellow #6, gelatin, glycerin", "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 antiflatulent (Antigas Fast Relief of: Gas Pressure Bloating Discomfort SOFTGELS †This product is not manufactured or distributed by C.B. Fleet Company, 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 BETTER LIBING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 www.betterlivingbrandsllc.com", "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: 2026-02-15T12:03:04.961919 · Updated: 2026-03-14T23:02:57.214195