phazyme ultimate 500 mg _0132-0222

SPL v2

SPL

SPL Set ID c8e9f6ac-2db2-4d21-a4b1-5ca6c3105662

Route

oral

Published

Effective Date 2025-10-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (500 mg)

Inactive Ingredients

fd&c blue no. 1 water gelatin glycerin medium-chain triglycerides silicon dioxide sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: PZ500 Shape: capsule Color: blue Size: 11 mm Score: 1

Marketing Status

otc monograph drug active Since 2024-02-01

Purpose

Anti-gas

Description

Drug Facts

Medication Information

Purpose

Anti-gas

Directions

Swallow (1) Fast Gel as symptoms occur
Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician

Other Information

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

Description

Drug Facts

Principal Display Panel

PHAZYME®

ANTI-GAS SIMETHICONE 500mg

ULTIMATE

500 MG

Questions?

Call toll-free 1-855-727-4277

Use

Relieves bloating, pressure, or fullness commonly referred to as gas.

Section 42229-5

Drug Facts

Inactive In

FD&C blue no. 1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, water

Active Ingredient

Simethicone 500mg

Stop Use and Ask A Doctor If

condition persists.

Structured Label Content

Purpose

Anti-gas

Directions

Swallow (1) Fast Gel as symptoms occur
Do not exceed (1) Fast Gel 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).

Principal Display Panel

PHAZYME®

ANTI-GAS SIMETHICONE 500mg

ULTIMATE

500 MG

Questions?

Call toll-free 1-855-727-4277

Use

Relieves bloating, pressure, or fullness commonly referred to as gas.

Section 42229-5 (42229-5)

Drug Facts

Inactive In

FD&C blue no. 1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, water

Active Ingredient

Simethicone 500mg

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": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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": ""}]

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 (1) Fast Gel as symptoms occur Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician", "Questions?": "Call toll-free 1-855-727-4277", "Inactive In": "FD&C blue no. 1, gelatin, glycerin, medium-chain triglycerides, silicon dioxide, sorbitol, water", "Active Ingredient": "Simethicone 500mg", "Other information": "Store at room temperature 59°- 86°F (15°-30°C).", "Principal Display Panel": "PHAZYME® ANTI-GAS SIMETHICONE 500mg ULTIMATE 500 MG", "Stop use and ask a doctor if": "condition persists."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:24.870997 · Updated: 2026-03-14T23:13:11.905913