simethicone 125 mg

SPL v1

SPL

SPL Set ID 078ef54e-96b2-4e2f-bebc-9b9bcda1f90a

Route

oral

Published

Effective Date 2024-09-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (125 mg)

Inactive Ingredients

sucrose maltodextrin peppermint sorbitol stearic acid dextrose, unspecified form microcrystalline cellulose silicon dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AP;040 Shape: round Color: white Size: 16 mm Score: 2

Marketing Status

otc monograph drug active Since 2018-04-25

Description

Drug Facts

Medication Information

Warnings

Keep out of reach of children

Directions

•
thoroughly chew 1-2 tablets as needed after meals and at bedtime
•
do not take more than 4 tablets per day

Other Information

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

Inactive Ingredients

compressible sugar, dextrose, maltodextrin, microcrystaline 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 82804-152-09

Simethicone 125 mg

ANTIFLATULENT

9 CHEWABLE TABLETS

*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH

Section 55105-1

Antiflatulent

Questions Or Comments?

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

Active Ingredient (in Each Chewable Tablet)

Simethicone 125 mg

Structured Label Content

Warnings

Keep out of reach of children

Directions

•
thoroughly chew 1-2 tablets as needed after meals and at bedtime
•
do not take more than 4 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, microcrystaline 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 82804-152-09

Simethicone 125 mg

ANTIFLATULENT

9 CHEWABLE TABLETS

*Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH

Section 55105-1 (55105-1)

Antiflatulent

Questions Or Comments? (Questions or comments?)

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

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

Simethicone 125 mg

Advanced Ingredient Data

[{"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "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": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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 82804-152-09 Simethicone 125 mg ANTIFLATULENT 9 CHEWABLE TABLETS *Compare to Active Ingredient in MYLANTA® GAS MAXIMUM STRENGTH", "55105-1": "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 than 4 tablets per day", "Other information": "store at room temperature 15°-30°C (59°-86°F)", "Inactive ingredients": "compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid", "Questions or comments?": "call 516-341-0666, 8:30 am -4:30 pm ET, Monday - Friday", "Active ingredient (in each chewable tablet)": "Simethicone 125 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.233684 · Updated: 2026-03-14T23:03:51.620726