Simethicone 80 Mg

SPL v1

SPL

SPL Set ID 2f8257ab-b588-4727-a989-2d4b6ef7770d

Route

ORAL

Published

Effective Date 2021-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (80 mg)

Inactive Ingredients

Microcrystalline Cellulose Silicon Dioxide Maltodextrin Sorbitol Stearic Acid Sucrose Dextrose, Unspecified Form Peppermint

Identifiers & Packaging

Pill Appearance

Imprint: AP;019 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-04-24

Description

Drug Facts

Purpose

Antiflatulent

How Supplied

Product: 50090-5431 NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE

Medication Information

Purpose

Antiflatulent

How Supplied

Product: 50090-5431

NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE

Description

Drug Facts

Use

relieves bloating, pressure and fullness commonly referred to as gas

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children

Warnings

Keep out of reach of children

Directions

thoroughly chew 1-2 tablets as needed after meals and at bedtime
do not take more then 6 tablets per day

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

Questions Or Comments?

call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Chewable Tablet)

Simethicone 80 mg

Simethicone 80 Mg (simethicone) Tablet, Chewable

Structured Label Content

Use

relieves bloating, pressure and fullness commonly referred to as gas

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

Antiflatulent

Warnings

Keep out of reach of children

Directions

thoroughly chew 1-2 tablets as needed after meals and at bedtime
do not take more then 6 tablets per day

How Supplied (HOW SUPPLIED)

Product: 50090-5431

NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am to 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Simethicone 80 mg

Simethicone 80 Mg (simethicone) Tablet, Chewable (SIMETHICONE 80 MG (SIMETHICONE) TABLET, CHEWABLE)

Advanced Ingredient Data

[{"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves bloating, pressure and fullness commonly referred to as gas", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children", "Purpose": "Antiflatulent", "Warnings": "Keep out of reach of children", "Directions": "thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more then 6 tablets per day", "HOW SUPPLIED": "Product: 50090-5431 NDC: 50090-5431-3 30 TABLET, CHEWABLE in a BOTTLE", "Other information": "store at room temperature 15°-30°C (59°-86°F)", "Inactive ingredients": "compressible sugar, dextrose, maltodextrin, micdocrystalline cellulose, peppermint flavor, Silicon dioxide, sorbitol, stearic acid", "Questions or comments?": "call 516-341-0666 , 8:30 am to 4:30 pm ET, Monday - Friday", "Active ingredient (in each chewable tablet)": "Simethicone 80 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:17.892261 · Updated: 2026-03-14T22:59:11.576282