Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 24b777e5-f0b5-400d-8ca9-ae0c04b8503b
Route
ORAL
Published
Effective Date 2025-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (500 mg)
Inactive Ingredients
D&c Red No. 27 Aluminum Lake Gelatin, Unspecified Glycerin Medium-chain Triglycerides Water Soybean Lecithin

Identifiers & Packaging

Pill Appearance
Imprint: GX500 Shape: oval Color: pink Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-13

Description

Simethicone 500 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 500 mg

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Directions
  • adults and children 12 years and older: swallow with water 1 softgel after meals or at bedtime
  • do not exceed 1 softgel in 24 hours except under the advice and supervision of a physician
Other Information
  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat and moisture
Inactive Ingredients

D&C red no. 27 aluminum lake, gelatin, glycerin, medium-chain triglycerides, pharmaceutical ink, purified water, soy lecithin

Additional Information

Gas-X Ultimate Strength

Softgels offer fast, effective relief of pressure and bloating. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

READ ALL PRODUCT INFORMATION BEFORE USING.

KEEP CARTON FOR IMPORTANT INFORMATION.

Gas-X Ultimate Strength Softgels contain liquid gas-fighting medicine in a softgels so they are easy to swallow.

TAMPER EVIDENT FEATURE:

Do not use if blister is broken or damaged.

1-800-452-0051

Dist. By: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2025 Haleon or licensor.

Questions Or Comments?

1-800-452-0051

Principal Display Panel

NEW!

HALEON

#1 DOCTOR RECOMMENDED BRAND

Gas-X

SIMETHICONE 500 mg / ANTIGAS

Goes to work in Minutes

RELIEVES GAS FAST

PRESSURE – BLOATING – DISCOMFORT

ULTIMATE STRENGTH

2X STRONGER*

STRONGEST OTC GAS RELIEF

*Than 1 Gas-X

Maximum Strength (250 mg)

GX500

20 SoftGels

Active Ingredient (in Each Softgel)

Simethicone 500 mg


Structured Label Content

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Purpose

Antigas

Directions
  • adults and children 12 years and older: swallow with water 1 softgel after meals or at bedtime
  • do not exceed 1 softgel in 24 hours except under the advice and supervision of a physician
Other Information (Other information)
  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)

D&C red no. 27 aluminum lake, gelatin, glycerin, medium-chain triglycerides, pharmaceutical ink, purified water, soy lecithin

Additional Information (Additional information)

Gas-X Ultimate Strength

Softgels offer fast, effective relief of pressure and bloating. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

READ ALL PRODUCT INFORMATION BEFORE USING.

KEEP CARTON FOR IMPORTANT INFORMATION.

Gas-X Ultimate Strength Softgels contain liquid gas-fighting medicine in a softgels so they are easy to swallow.

TAMPER EVIDENT FEATURE:

Do not use if blister is broken or damaged.

1-800-452-0051

Dist. By: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2025 Haleon or licensor.

Questions Or Comments? (Questions or comments?)

1-800-452-0051

Principal Display Panel

NEW!

HALEON

#1 DOCTOR RECOMMENDED BRAND

Gas-X

SIMETHICONE 500 mg / ANTIGAS

Goes to work in Minutes

RELIEVES GAS FAST

PRESSURE – BLOATING – DISCOMFORT

ULTIMATE STRENGTH

2X STRONGER*

STRONGEST OTC GAS RELIEF

*Than 1 Gas-X

Maximum Strength (250 mg)

GX500

20 SoftGels

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

Simethicone 500 mg


Advanced Ingredient Data


Raw Label Data

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