Extra Strength Gas Relief

SPL v2

SPL

SPL Set ID 2c3a05de-6690-f49a-e063-6394a90a9085

Route

ORAL

Published

Effective Date 2025-02-05

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

D&c Red No. 30 Aluminum Lake Magnesium Stearate Cellulose, Microcrystalline Sorbitol Sucrose Maltodextrin Dextrose, Unspecified Form D&c Yellow No. 10 Aluminum Lake

Identifiers & Packaging

Pill Appearance

Imprint: G134 Shape: round Color: yellow Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-05

Description

Simethicone 125 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 125 mg

Use(s)

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

Directions

adults and children 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

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

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

Harris Teeter™

NDC 69256-135-73

EXSTRA STRENGTH

GAS RELIEF

Antigas. Simethicone 125 mg

Relieves:

Pressure

Bloating

Gas Distress

Compare to the Active Ingredient in Gas-X^® Extra Strength*

Mint Flavor

18 chewable tablets

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
symptoms referred to as gas

Purpose (PURPOSE)

Anti-gas

Warnings (WARNINGS)

Directions (DIRECTIONS)

adults and children 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 (OTHER INFORMATION)

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40ºC (104ºF)

Inactive Ingredients (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 (PRINCIPAL DISPLAY PANEL)

Harris Teeter™

NDC 69256-135-73

EXSTRA STRENGTH

GAS RELIEF

Antigas. Simethicone 125 mg

Relieves:

Pressure

Bloating

Gas Distress

Compare to the Active Ingredient in Gas-X^® Extra Strength*

Mint Flavor

18 chewable tablets

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": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 30 ALUMINUM LAKE", "unii": "GE75M6YV5W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: pressure bloating symptoms referred to as gas", "PURPOSE": "Anti-gas", "WARNINGS": ".", "DIRECTIONS": "adults and children 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": "do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF)", "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": "Harris Teeter™ NDC 69256-135-73 EXSTRA STRENGTH GAS RELIEF Antigas. Simethicone 125 mg Relieves: Pressure Bloating Gas Distress Compare to the Active Ingredient in Gas-X ® Extra Strength* Mint Flavor 18 chewable tablets ", "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: 2026-02-15T12:05:29.409376 · Updated: 2026-03-14T23:07:22.014703