57d31610-c658-49cf-9de3-01e8143aeace

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

Purpose

Antigas

Description

Simethicone 250 mg

Medication Information

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

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.

Description

Simethicone 250 mg

Questions?

call 1-800-630-8895

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 ^®

Drug Facts

Active Ingredient (in Each Softgel)

Simethicone 250 mg

Structured Label Content

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

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.

Questions?

call 1-800-630-8895

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 ^®

Drug Facts

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

Simethicone 250 mg

Advanced Ingredient Data

[{"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "for the relief of pressure, bloating, and fullness, commonly referred to as gas.", "42229-5": "Distributed by: Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A.", "50565-1": "If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.", "50569-3": "Stop use and ask a doctor if condition persists", "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", "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"}

Additional Information

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