SPL v1
SPL
SPL Set ID 57d31610-c658-49cf-9de3-01e8143aeace
Route
ORAL
Published
Effective Date 2024-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (250 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Blue No. 1 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance
Imprint: PC31 Shape: oval Color: purple Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-30
Description

Simethicone 250 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 250 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 50569-3

Stop use and ask a doctor if condition persists

Section 51945-4

NDC 80513-112-01

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

HIGH POTENCY

GAS RELIEF

Simethicone 250 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

100 SOFTGELS

†This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ®

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 2 softgels in 24 hours except under the advice and supervision of a physician
Drug Facts

Questions?

call 1-800-630-8895

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

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.

Active Ingredient (in Each Softgel)

Simethicone 250 mg

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 50569-3 (50569-3)

Stop use and ask a doctor if condition persists

Section 51945-4 (51945-4)

NDC 80513-112-01

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

HIGH POTENCY

GAS RELIEF

Simethicone 250 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

100 SOFTGELS

†This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ®

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 2 softgels in 24 hours except under the advice and supervision of a physician
Drug Facts

Questions?

call 1-800-630-8895

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)

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.

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

Simethicone 250 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.423663 · Updated: 2026-03-14T23:03:35.185430