72de768c-c011-433b-be27-f1978d18f7d8

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

Purpose

Antigas

Description

Simethicone 125 mg

Medication Information

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 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.

Description

Simethicone 125 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 51945-4

NDC 80513-111-12

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

120 SOFTGELS

Drug Facts

Active Ingredient

Simethicone 125 mg

Structured Label Content

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 (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.

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 51945-4 (51945-4)

NDC 80513-111-12

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg

• RELIEVES GAS FAST

• PRESSURE

• BLOATING

• DISCOMFORT

120 SOFTGELS

Drug Facts

Active Ingredient (Active ingredient)

Simethicone 125 mg

Advanced Ingredient Data

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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.", "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", "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."}

Additional Information

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