Gas Relief

Gas Relief
SPL v1
SPL
SPL Set ID 5dcd50ae-370d-4e49-b981-db42b86c2ecb
Route
ORAL
Published
Effective Date 2025-01-16
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 Water Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 911 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01
Description

Active Ingredients (in each softgel) Simethicone 125 mg

Medication Information

Indications and Usage

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

Description

Active Ingredients (in each softgel) Simethicone 125 mg

Section 42229-5

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Section 51727-6

D&C Yellow 10, FD&C Blue 1, Edible Ink, Gelatin, Glycerin, Peppermint oil, POLYSORB, Purified water, Titanium dioxide.

Section 51945-4

NDC 80513-117-12

Extra Strength

GAS RELIEF

Simethicone 125 mg

Section 53413-1

Questions?



call 1-800-630-8895

Section 55105-1

Purpose

Antigas

Section 55106-9

Active Ingredients (in each softgel)

Simethicone 125 mg

Warning

If pregnant or breast-feeding,ask a health professional before use.

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
Drug Facts

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • protect from light, heat and moisture
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Keep Out of Reach of Children.

Structured Label Content

Indications and Usage (34067-9)

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

Section 42229-5 (42229-5)

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Section 51727-6 (51727-6)

D&C Yellow 10, FD&C Blue 1, Edible Ink, Gelatin, Glycerin, Peppermint oil, POLYSORB, Purified water, Titanium dioxide.

Section 51945-4 (51945-4)

NDC 80513-117-12

Extra Strength

GAS RELIEF

Simethicone 125 mg

Section 53413-1 (53413-1)

Questions?



call 1-800-630-8895

Section 55105-1 (55105-1)

Purpose

Antigas

Section 55106-9 (55106-9)

Active Ingredients (in each softgel)

Simethicone 125 mg

Warning

If pregnant or breast-feeding,ask a health professional before use.

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
Drug Facts

Other Information
  • store at 20° to 25°C (68° to 77°F)
  • protect from light, heat and moisture
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Keep Out of Reach of Children. (Keep out of reach of children.)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.083188 · Updated: 2026-03-14T23:07:03.829205