Extra Strength Gas Relief Tablets

SPL v6

SPL

SPL Set ID cbbd43eb-1155-4e0d-bed4-32343f34b503

Route

ORAL

Published

Effective Date 2025-10-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

D&c Yellow No. 10 Dextrose, Unspecified Form Magnesium Stearate Maltodextrin Microcrystalline Cellulose Silicon Dioxide Sucralose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance

Imprint: RP110 Shape: round Color: yellow Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Simethicone 125 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 125 mg

Use(s)

relieves:

Pressure, bloating and fullness commonly referred to as gas

Directions

adults and Childrens 12 years and older:chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other Information

each tablet contains:calcium 45 mg
store at room temperature
protect from moisture

Inactive Ingredients

D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

*Compare to the active ingredient in Gas-X Extra Strength

NDC 21130-441-48

Extra strength

Gas Relief

Simethicone 125 mg/Anti-Gas

Fast Relief of Pressure, Bloating & Discomfort

Peppermint Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength.

IMPORTANT: Keep this carton for future reference on full labeling.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a poison control center immediately.

Active Ingredient (in Each Tablet)

Simethicone 125 mg

Structured Label Content

Use(s) (USE(S))

relieves:

Pressure, bloating and fullness commonly referred to as gas

Purpose (PURPOSE)

Anti-gas

Directions

adults and Childrens 12 years and older:chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other Information

each tablet contains:calcium 45 mg
store at room temperature
protect from moisture

Inactive Ingredients

D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

*Compare to the active ingredient in Gas-X Extra Strength

NDC 21130-441-48

Extra strength

Gas Relief

Simethicone 125 mg/Anti-Gas

Fast Relief of Pressure, Bloating & Discomfort

Peppermint Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength.

IMPORTANT: Keep this carton for future reference on full labeling.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a poison control center immediately.

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Simethicone 125 mg

Advanced Ingredient Data

[{"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: Pressure, bloating and fullness commonly referred to as gas", "PURPOSE": "Anti-gas", "Directions": "adults and Childrens 12 years and older: chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician", "Other Information": "each tablet contains: calcium 45 mg store at room temperature protect from moisture", "Inactive Ingredients": "D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose", "Principal Display Panel": "*Compare to the active ingredient in Gas-X Extra Strength NDC 21130-441-48 Extra strength Gas Relief Simethicone 125 mg/Anti-Gas Fast Relief of Pressure, Bloating & Discomfort Peppermint Flavor Naturally and Artificially Flavored 18 Chewable Tablets *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength. IMPORTANT : Keep this carton for future reference on full labeling.", "Keep out of reach of children": "In case of overdose, get medical help or contact a poison control center immediately.", "Active Ingredient (in each tablet)": "Simethicone 125 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:13.586649 · Updated: 2026-03-14T23:13:20.000214