SPL v1
SPL
SPL Set ID 72de768c-c011-433b-be27-f1978d18f7d8
Route
ORAL
Published
Effective Date 2024-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: YH3 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-30
Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Use

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

Section 42229-5

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

Section 50565-1

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

Keep out of reach of children.

Section 51945-4

NDC 80513-111-12

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

120 SOFTGELS

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

Questions?

call 1-800-630-8895

Active Ingredient

Simethicone 125 mg

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
Inactive Ingredients

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.

Structured Label Content

Use

for the relief of pressure, bloating, and 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 50565-1 (50565-1)

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

Keep out of reach of children.

Section 51945-4 (51945-4)

NDC 80513-111-12

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

120 SOFTGELS

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
Drug Facts

Questions?

call 1-800-630-8895

Active Ingredient (Active ingredient)

Simethicone 125 mg

Other Information (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
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.424721 · Updated: 2026-03-14T23:03:35.185430