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

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

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

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 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

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

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

Back to search View SPL set listing Open on DailyMed ↗

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