Major Simethicone

SPL v5

SPL

SPL Set ID d321114e-09ac-4252-a6e6-3dbc3a451ee6

Route

ORAL

Published

Effective Date 2025-12-03

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (80 mg)

Inactive Ingredients

Sugarcane Maltodextrin Dextrose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: G;103 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-04

Description

Simethicone 80 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 80 mg

Use(s)

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

Questions

Call (800) 616-2471

Directions

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
do not exceed 6 tablets per day unless directed by a physician

Other Information

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40^oC (104^oF)

Inactive Ingredients

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

Principal Display Panel

NDC 0904-7206-60

MAJOR

Simethicone

Simethicone 80 mg

antiflatulent

relieves:

gas pain
pressure
bloating

100 Chewable Tablets

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Active Ingredient(in Each Tablet)

Simethicone 80 mg

Structured Label Content

Use(s) (USE(S))

relieves:

pressure
bloating
symptoms referred to as gas

Purpose (PURPOSE)

Antigas

Warnings (WARNINGS)

Questions (QUESTIONS)

Call (800) 616-2471

Directions (DIRECTIONS)

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
do not exceed 6 tablets per day unless directed by a physician

Other Information (OTHER INFORMATION)

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40^oC (104^oF)

Inactive Ingredients (INACTIVE INGREDIENTS)

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0904-7206-60

MAJOR

Simethicone

Simethicone 80 mg

antiflatulent

relieves:

gas pain
pressure
bloating

100 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 (1-800-222-1222) immediately.

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

Simethicone 80 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SUGARCANE", "unii": "81H2R5AOH3", "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": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: pressure bloating symptoms referred to as gas", "PURPOSE": "Antigas", "WARNINGS": ".", "QUESTIONS": "Call (800) 616-2471", "DIRECTIONS": "chew 2 to 4 tablets thoroughly as needed after meals and at bedtime do not exceed 6 tablets per day unless directed by a physician", "OTHER INFORMATION": "do not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)", "INACTIVE INGREDIENTS": "compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.", "PRINCIPAL DISPLAY PANEL": "NDC 0904-7206-60 MAJOR Simethicone Simethicone 80 mg antiflatulent relieves: gas pain pressure bloating 100 Chewable Tablets", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. ", "ACTIVE INGREDIENT(in each tablet)": "Simethicone 80 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:26.620167 · Updated: 2026-03-14T23:10:53.901398