Maximum Strength Gas Relief

SPL v2

SPL

SPL Set ID c37def6e-bb10-41ba-8bce-b06c09edbe9f

Route

ORAL

Published

Effective Date 2016-10-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (250 mg)

Inactive Ingredients

D&c Red No. 33 Fd&c Blue No. 1 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC31 Shape: capsule Color: purple Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-10-05

Description

Simethicone 250 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Use

relieves bloating, pressure or fullness commonly referred to as gas

Section 50565-1

Keep out of reach of children.

Directions

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

Other Information

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions Or Comments?

Call: 1-855-215-8180

Principal Display Panel

CAREONE MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 41520-983-02

Compare to the active ingredient in PHAZYME® Maximum Strength

12 Liquid-Filled SoftGels

Stop Use and Ask A Doctor If

condition persists

Active Ingredient (in Each Softgel)

Simethicone 250 mg

Structured Label Content

Use

relieves bloating, pressure or fullness commonly referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-gas

Directions

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

Other Information (Other information)

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients (Inactive ingredients)

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions Or Comments? (Questions or comments?)

Call: 1-855-215-8180

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CAREONE MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 41520-983-02

Compare to the active ingredient in PHAZYME® Maximum Strength

12 Liquid-Filled SoftGels

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

condition persists

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

Simethicone 250 mg

Advanced Ingredient Data

[{"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves bloating, pressure or fullness commonly referred to as gas", "50565-1": "Keep out of reach of children.", "Purpose": "Anti-gas", "Directions": "swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "Other information": "store at room temperature 59°-86°F (15°-30°C)", "Inactive ingredients": "D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink", "Questions or comments?": "Call : 1-855-215-8180", "PRINCIPAL DISPLAY PANEL": "CAREONE MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 mg Anti-gas NDC 41520-983-02 Compare to the active ingredient in PHAZYME® Maximum Strength 12 Liquid-Filled SoftGels", "Stop use and ask a doctor if": "condition persists", "Active ingredient (in each softgel)": "Simethicone 250 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.806451 · Updated: 2026-03-14T23:05:18.894850