Simethicone Capsules 250 Mg, Liquid Filled

SPL v1

SPL

SPL Set ID 43126f66-e90b-4de9-bb6f-3240de4f2ba6

Route

ORAL

Published

Effective Date 2016-12-13

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-12-13

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 toll free: 1-855-215-8180

Principal Display Panel

CVS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 69842-068-04

Compare to the active ingredient in PHAZYME® Maximum Strength

24 Liquid-Filled SoftGels

CVS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 69842-068-22

Compare to the active ingredient in PHAZYME® Maximum Strength

60 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 toll free: 1-855-215-8180

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CVS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 69842-068-04

Compare to the active ingredient in PHAZYME® Maximum Strength

24 Liquid-Filled SoftGels

CVS MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 69842-068-22

Compare to the active ingredient in PHAZYME® Maximum Strength

60 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": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": ""}]

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 toll free: 1-855-215-8180", "PRINCIPAL DISPLAY PANEL": "CVS MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 mg Anti-gas NDC 69842-068-04 Compare to the active ingredient in PHAZYME® Maximum Strength 24 Liquid-Filled SoftGels CVS MAXIMUM STRENGTH GAS RELIEF SIMETHICONE 250 mg Anti-gas NDC 69842-068-22 Compare to the active ingredient in PHAZYME® Maximum Strength 60 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: 2026-02-15T11:56:13.560164 · Updated: 2026-03-14T22:54:33.877898