Ultra Strength Gas Relief

SPL v3

SPL

SPL Set ID d33e413d-4add-459f-ba46-c23b49cfcc87

Route

ORAL

Published

Effective Date 2021-11-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2018-03-27

Description

Drug Facts

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Drug Facts

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor ifcondition persists

Directions

swallow 1 or 2 softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other Information

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 60 Softgels

NDC 0363-9942-22

*Compare to the active ingredient in PHAZYME ^®Ultra Strength

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcondition persists

Purpose

Anti-gas

Directions

swallow 1 or 2 softgels as needed after a meal
do not exceed two softgels per day except under the advice and supervision of a physician

Other Information (Other information)

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients (Inactive ingredients)

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas 60 Softgels

NDC 0363-9942-22

*Compare to the active ingredient in PHAZYME ^®Ultra Strength

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 180 mg

Advanced Ingredient Data

[{"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": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating, pressure or fullness commonly referred to as gas", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . ", "50566-9": "Stop use and ask a doctor if condition persists", "Purpose": "Anti-gas", "Directions": "swallow 1 or 2 softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician", "Other information": "store at room temperature 59º - 86ºF (15º - 30ºC)", "Inactive ingredients": "FD&C yellow#6, gelatin, glycerin, purified water and white edible ink", "Questions or comments?": "Call toll free: 1-855-215-8180", "PRINCIPAL DISPLAY PANEL": "Ultra Strength Gas Relief Simethicone 180 mg Anti-gas 60 Softgels NDC 0363-9942-22 *Compare to the active ingredient in PHAZYME ® Ultra Strength", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.814360 · Updated: 2026-03-14T23:05:18.894850