Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cce7f7db-99b8-4d7d-ac77-43da6323ebe1
Route
ORAL
Published
Effective Date 2024-03-04
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 2024-03-01
Description

Simethicone 180 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 180 mg

Use
  • relieves bloating, pressure, or fullness commonly referred to as gas
Directions
  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Product Label
LEADER Ultra Strength Gas Relief
Other Information
  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture
Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, water

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH active ingredient*

Ultra Strength

Gas Relief

Simethicone, 180 mg

Antigas

fast relief of:

  • Gas
  • Pressure
  • Bloating
  • Discomfort

Softgels

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Stop Use and Ask A Doctor If

condition persists.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Use
  • relieves bloating, pressure, or fullness commonly referred to as gas
Purpose

Antigas

Directions
  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Product Label
LEADER Ultra Strength Gas Relief
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture
Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, water

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH active ingredient*

Ultra Strength

Gas Relief

Simethicone, 180 mg

Antigas

fast relief of:

  • Gas
  • Pressure
  • Bloating
  • Discomfort

Softgels

*This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

condition persists.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

Simethicone 180 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.892111 · Updated: 2026-03-14T23:02:36.495120