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

Purpose

Antiflatulent

Description

Drug Facts

Medication Information

Warnings

Keep out of reach of children

Purpose

Antiflatulent

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

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

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

Warnings

Keep out of reach of children

Purpose

Antiflatulent

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

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

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