Phazyme Maximum Strength 250 Mg 0132 - 0211

SPL v10

SPL

SPL Set ID ea04f5a5-cf56-4176-a234-5a73e01ff218

Route

ORAL

Published

Effective Date 2025-10-23

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 Medium-chain Triglycerides Silicon Dioxide Sorbitol Water

Identifiers & Packaging

Pill Appearance

Imprint: PZ;250 Shape: capsule Color: purple Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-04-01

Description

Drug Facts

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Drug Facts

Use

Relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5

Drug Facts

Directions

Swallow one or two fast gels as symptoms occur.
Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician.

Questions?

Call toll-free 1-855-727-4277

Inactive In

DC Red #33, FD&C Blue #1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, purified water

Active Ingredient

Simethicone 250 mg

Other Information

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

Principal Display Panel

PHAZYME®

ANTI-GAS SIMETHICONE 250 mg

MAXIMUM

STRENGTH

250 MG

12 FAST GELS

Stop Use and Ask A Doctor If

condition persists.

Structured Label Content

Use

Relieves bloating, pressure or fullness commonly referred to as gas

Section 42229-5 (42229-5)

Drug Facts

Purpose

Anti-gas

Directions

Swallow one or two fast gels as symptoms occur.
Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician.

Questions?

Call toll-free 1-855-727-4277

Inactive In

DC Red #33, FD&C Blue #1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, purified water

Active Ingredient

Simethicone 250 mg

Other Information (Other information)

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

Principal Display Panel

PHAZYME®

ANTI-GAS SIMETHICONE 250 mg

MAXIMUM

STRENGTH

250 MG

12 FAST GELS

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

condition persists.

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": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "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", "42229-5": "Drug Facts", "Purpose": "Anti-gas", "Directions": "Swallow one or two fast gels as symptoms occur. Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician.", "Questions?": "Call toll-free 1-855-727-4277", "Inactive In": "DC Red #33, FD&C Blue #1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, purified water", "Active Ingredient": "Simethicone 250 mg", "Other information": "Store at room temperature 59º-86ºF (15º-30ºC). ", "Principal Display Panel": "PHAZYME® ANTI-GAS SIMETHICONE 250 mg MAXIMUM STRENGTH 250 MG 12 FAST GELS ", "Stop use and ask a doctor if": "condition persists."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.902350 · Updated: 2026-03-14T23:13:13.649161