Simethicone 125 Mg

SPL v4

SPL

SPL Set ID 4ce98db3-c7a6-4627-88c5-9de302a53188

Route

ORAL

Published

Effective Date 2022-09-29

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 Cellulose, Microcrystalline 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

How Supplied

NDC 17856-0137-01 Box of 100 Chewable Tablets.................................. 17856-0137-01 ANTIFLATULENT

Medication Information

How Supplied

NDC 17856-0137-01

Box of 100 Chewable Tablets.................................. 17856-0137-01

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

Section 55105-1

Antiflatulent

Warnings

Keep out of reach of children

TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN

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?

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Call 1-800-509-7592

M-F 8 am - 5 pm EST

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)

Section 55105-1 (55105-1)

Antiflatulent

Warnings

Keep out of reach of children

TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN

Directions

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

How Supplied

NDC 17856-0137-01

Box of 100 Chewable Tablets.................................. 17856-0137-01

ANTIFLATULENT

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?)

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Call 1-800-509-7592

M-F 8 am - 5 pm EST

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": "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", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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", "55105-1": "Antiflatulent", "Warnings": "Keep out of reach of children TAMPER EVIDENT: DO NOT USE IF SAFETY POUCH LOOKS TO BE TEMPERED OR OPEN", "Directions": "thoroughly chew 1-2 tablets as needed after meals and at bedtime do not take more than 4 tablets per day", "How Supplied": "NDC 17856-0137-01 Box of 100 Chewable Tablets.................................. 17856-0137-01 ANTIFLATULENT", "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?": "Distributed by: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179 Call 1-800-509-7592 M-F 8 am - 5 pm EST", "Active ingredient (in each chewable tablet)": "Simethicone 125 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:25.483904 · Updated: 2026-03-14T23:09:12.253423