Ultra Strength Gas Relief

SPL v5

SPL

SPL Set ID 68446b51-aa41-4684-9968-06f54f85504e

Route

ORAL

Published

Effective Date 2020-03-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (180 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Gelatin Glycerin Peppermint Oil Water Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 161 Shape: oval Color: orange Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-03-10

Description

Drug Facts

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Drug Facts

Use

for the relief of

■ pressure and bloating commonly referred to as gas

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Warnings

Keep out of reach of children.

Directions

■ adults: 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 controlled room temperature 20-25°C (68-77°F)

■ protect from heat and moisture

Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide

Principal Display Panel

ULTRA STRANGTH

GAS RELIEF

Simethicone 180 mg /

anti-gas

Fast relief of:

• bloating

• pressure

• fullness

• gas

50 SOFTGELS

Questions Or Comments?

1-888-333-9792

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Use

for the relief of

■ pressure and bloating commonly referred to as gas

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antigas

Warnings

Keep out of reach of children.

Directions

■ adults: 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 controlled room temperature 20-25°C (68-77°F)

■ protect from heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ULTRA STRANGTH

GAS RELIEF

Simethicone 180 mg /

anti-gas

Fast relief of:

• bloating

• pressure

• fullness

• gas

50 SOFTGELS

Questions Or Comments? (Questions or comments? )

1-888-333-9792

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

Simethicone 180 mg

Advanced Ingredient Data

[{"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "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": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "for the relief of ■ pressure and bloating commonly referred to as gas", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "Purpose": "Antigas", "Warnings": "Keep out of reach of children.", "Directions": "■ adults: 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 controlled room temperature 20-25°C (68-77°F) ■ protect from heat and moisture", "Inactive ingredients": "FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "ULTRA STRANGTH GAS RELIEF Simethicone 180 mg / anti-gas Fast relief of: • bloating • pressure • fullness • gas 50 SOFTGELS", "Questions or comments? ": "1-888-333-9792", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:48.424991 · Updated: 2026-03-14T23:05:48.377821