Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 4120832d-6c98-43f6-bdac-c88376c88c30
Route
ORAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Peppermint Oil Water Sorbitan Sorbitol Titanium Dioxide Mannitol

Identifiers & Packaging

Pill Appearance
Imprint: PO Shape: oval Color: green Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-07-31 Until 2027-02-01
Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas.

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 physican
Product Label
READYinCASE Extra Strength Gas Relief
Other Information
  • store between 20-25°C (68-77°F)
  • do not refrigerate 
  • protect from light, heat, and moisture
Inactive Ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide



Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Gas-X® Extra Strength†

extra strength

gas relief

simethicone 125 mg

anti-gas

Relieves:

  • Pressure
  • bloating
  • discomfort

softgels

small, easy to swallow

†This product is not manufactured or distributed by Haleon group of companies, distributor of Gas-X® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas.

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 physican
Product Label
READYinCASE Extra Strength Gas Relief
Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not refrigerate 
  • protect from light, heat, and moisture
Inactive Ingredients (Inactive ingredients)

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide



Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Gas-X® Extra Strength†

extra strength

gas relief

simethicone 125 mg

anti-gas

Relieves:

  • Pressure
  • bloating
  • discomfort

softgels

small, easy to swallow

†This product is not manufactured or distributed by Haleon group of companies, distributor of Gas-X® Extra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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 125 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:01.655160 · Updated: 2026-03-14T23:10:29.645873