Extra Strength Gas Relief

Extra Strength Gas Relief
SPL v3
SPL
SPL Set ID a2d1fc2d-6bb1-459d-900a-7e4f329792b1
Route
ORAL
Published
Effective Date 2021-01-20
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 Gelatin Glycerin Peppermint Oil Povidone K30 Sorbitol Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-01-19
Description

Simethicone 125mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125mg

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Directions
  • adults: 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

FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Keep Out of Reach of Children.

Active Ingredient (in Each Softgel)

Simethicone 125mg

Principal Display Panel Shipping Label

IMETHICONE CAPSULES, 325 mg

Quantity : 48 Bags of 1500 Capsules each

NDC. No : 55629-010-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only

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

Structured Label Content

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Purpose

Antigas

Directions
  • adults: 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 (Inactive ingredients)

FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Simethicone 125mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

IMETHICONE CAPSULES, 325 mg

Quantity : 48 Bags of 1500 Capsules each

NDC. No : 55629-010-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:39.104344 · Updated: 2026-03-14T23:01:06.342894