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
Purpose

Antigas

Description

Simethicone USP, 125 mg

Medication Information

Warnings

Purpose

Antigas

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

Description

Simethicone USP, 125 mg

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

Use

for the relief of

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

Keep out of reach of children

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Simethicone USP, 125 mg

Structured Label Content

Warnings

Purpose

Antigas

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

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

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

Questions Or Comments? (Questions or comments?)

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

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

Back to search View SPL set listing Open on DailyMed ↗

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