Simethicone 80 Mg

SPL v12

SPL

SPL Set ID 32fb242b-7051-072c-e054-00144ff88e88

Route

ORAL

Published

Effective Date 2015-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (80 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-04-24

Description

Drug Facts

Purpose

Antiflatulent

Medication Information

Purpose

Antiflatulent

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

Section 51945-4

NDC 69618-033-01

Simethicone 80 mg

ANTIFLATULENT

100 CHEWABLE TABLETS

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

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

Section 51945-4 (51945-4)

NDC 69618-033-01

Simethicone 80 mg

ANTIFLATULENT

100 CHEWABLE TABLETS

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

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

Advanced Ingredient Data

[{"name": "CELLULOSE, MICROCRYSTALLINE", "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", "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", "51945-4": "NDC 69618-033-01 Simethicone 80 mg ANTIFLATULENT 100 CHEWABLE TABLETS", "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", "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: 2026-02-15T12:05:22.065977 · Updated: 2026-03-14T23:07:03.829205