Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 853f5f52-8fe1-473f-b68d-295115222120

Route

ORAL

Published

Effective Date 2024-05-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dimethicone (180 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-03-31

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

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

Product Label

FOSTER & THRIVE Ultra Strength Gas Relief

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Gas Relief

Simethicone 180 mg

ANTIGAS

Relieves Gas Symptoms

Relief of:

Gas
Pressure
Bloating
Fullness

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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphic, TN 38141

www.fosterandthrive.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

Product Label

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

Questions Or Comments? (Questions or comments?)

Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH

Gas Relief

Simethicone 180 mg

ANTIGAS

Relieves Gas Symptoms

Relief of:

Gas
Pressure
Bloating
Fullness

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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC.

Memphic, TN 38141

www.fosterandthrive.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 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": "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": "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", "Product Label": "FOSTER & THRIVE Ultra Strength Gas Relief", "Other information": "store between 15-30ºC (59-86ºF) protect from heat and moisture", "Inactive ingredients": "FD&C red #40 FD&C yellow #6, gelatin, glycerin", "Questions or comments?": "Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "Principal Display Panel": "COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT* ULTRA STRENGTH Gas Relief Simethicone 180 mg ANTIGAS Relieves Gas Symptoms Relief of: Gas Pressure Bloating Fullness 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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Distributed by McKesson Corp., via Strategic Sourcing Services LLC. Memphic, TN 38141 www.fosterandthrive.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: 2026-02-15T12:03:08.549496 · Updated: 2026-03-14T23:03:01.087200