Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 708cbbf2-4923-4cbf-b71c-c8bb2ce80e63

Route

ORAL

Published

Effective Date 2024-05-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dimethicone (180 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance

Imprint: 05A Shape: capsule Color: orange Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-24

Description

Simethicone 180 mg

Purpose

Antigas

How Supplied

Product: 50090-6088 NDC: 50090-6088-0 1440 CAPSULE, LIQUID FILLED in a CASE

Medication Information

Purpose

Antigas

How Supplied

Product: 50090-6088

NDC: 50090-6088-0 1440 CAPSULE, LIQUID FILLED in a CASE

Description

Simethicone 180 mg

Uses

relieves bloating, pressure, or fullness commonly referred to as gas

Directions

swallow one or two softgels as symptoms occur
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Simethicone

Other Information

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin

Questions Or Comments?

Call 1-800-645-2158

Stop Use and Ask A Doctor If

condition persists.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Uses

relieves bloating, pressure, or fullness commonly referred to as gas

Purpose

Antigas

Directions

swallow one or two softgels as symptoms occur
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Simethicone

How Supplied (HOW SUPPLIED)

Product: 50090-6088

NDC: 50090-6088-0 1440 CAPSULE, LIQUID FILLED in a CASE

Other Information (Other information)

store between 15-30ºC (59-86ºF)
protect from heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin

Questions Or Comments? (Questions or comments?)

Call 1-800-645-2158

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 180 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating, pressure, or fullness commonly referred to as gas", "Purpose": "Antigas", "Directions": "swallow one or two softgels as symptoms occur do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "HOW SUPPLIED": "Product: 50090-6088 NDC: 50090-6088-0 1440 CAPSULE, LIQUID FILLED in a CASE", "Other information": "store between 15-30ºC (59-86ºF) protect from heat and moisture", "Inactive ingredients": "FD&C red #40, FD&C yellow #6, gelatin, glycerin", "Questions or comments?": "Call 1-800-645-2158", "Stop use and ask a doctor if": "condition persists.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:07.705269 · Updated: 2026-03-14T23:02:59.869199