Simethicone Capsules Usp, 125 Mg

Simethicone Capsules Usp, 125 Mg
SPL v1
SPL
SPL Set ID b3069d83-5654-8469-302a-0f76c30e3976
Route
ORAL
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
D&c Yellow No. 10 Titanium Dioxide Gelatin Peppermint Oil Sorbitol Fd&c Blue No. 1 Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-26
Description

Simethicone USP, 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone USP, 125 mg

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 50565-1

Keep out of reach of children

Warnings

Directions

  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat and moisture
Inactive Ingredients

D&C yellow no.10, FD&C blue no. 1, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)

Principal Display Panel

NDC 75907-365-30

Compare to Extra Strength Gas-X ® active ingredient*

Gas Relief

Simethicone Capsules USP, 125 mg

Antigas

Relieves Gas Fast

Pressure, Bloating, Discomfort

30 Softgels

*This product is not manufactured or distributed by GSK Consumer Healthcare. Haleon CH SARL is the owner of the registered trademark Gas-X®.

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

REV 12/25

Made in India

Active Ingredient (in Each Softgel)

Simethicone USP, 125 mg

Structured Label Content

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

Antigas

Warnings

Directions

  • adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information (Other information)

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)

D&C yellow no.10, FD&C blue no. 1, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)

Principal Display Panel

NDC 75907-365-30

Compare to Extra Strength Gas-X ® active ingredient*

Gas Relief

Simethicone Capsules USP, 125 mg

Antigas

Relieves Gas Fast

Pressure, Bloating, Discomfort

30 Softgels

*This product is not manufactured or distributed by GSK Consumer Healthcare. Haleon CH SARL is the owner of the registered trademark Gas-X®.

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

REV 12/25

Made in India

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

Simethicone USP, 125 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:57.327134 · Updated: 2026-03-14T23:12:00.901105