SPL v1
SPL
SPL Set ID 3948c0e5-4ee7-5443-e063-6294a90ad6ae
Route
ORAL
Published
Effective Date 2025-07-31
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 Water Titanium Dioxide Hypromelloses Lecithin, Soybean Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: S180 Shape: oval Color: orange Size: 12 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-31
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use

Relieves pressure, bloating, or fullness commonly referred to as gas

Dosage and Administration

Directions

  • Adults: Swallow 1 or 2 softgels with at least 8 oz of water, as needed after a meal or at bedtime.
  • Do not eceed 2 softgels in 24 hours except under the advice and supervision of a physician.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Store at room temperature 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children

Section 50566-9

Stop use and ask doctor if condition persists

Section 51727-6

Inactive ingredients FD&C Yellow No. 6, gelatin, glycerin, hypromellose, lecithin, titanium dioxide, water

Section 51945-4

curist

Gas Relief

Simethicone 180 mg

Anti-Gas

Relief of Gas, Pressure, Bloating, and Fullness

365 Softgels

Section 53413-1

Questions or Comments?

Call 1-800-243-1241 or email [email protected]

Section 53414-9

If pregant or breast feeding, ask a health profession before use

Section 55105-1

Purpose

Antigas

Section 55106-9

Active Ingredient (in each softgel)

Simethicone 180 mg

Structured Label Content

Indications and Usage (34067-9)

Use

Relieves pressure, bloating, or fullness commonly referred to as gas

Dosage and Administration (34068-7)

Directions

  • Adults: Swallow 1 or 2 softgels with at least 8 oz of water, as needed after a meal or at bedtime.
  • Do not eceed 2 softgels in 24 hours except under the advice and supervision of a physician.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

Store at room temperature 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask doctor if condition persists

Section 51727-6 (51727-6)

Inactive ingredients FD&C Yellow No. 6, gelatin, glycerin, hypromellose, lecithin, titanium dioxide, water

Section 51945-4 (51945-4)

curist

Gas Relief

Simethicone 180 mg

Anti-Gas

Relief of Gas, Pressure, Bloating, and Fullness

365 Softgels

Section 53413-1 (53413-1)

Questions or Comments?

Call 1-800-243-1241 or email [email protected]

Section 53414-9 (53414-9)

If pregant or breast feeding, ask a health profession before use

Section 55105-1 (55105-1)

Purpose

Antigas

Section 55106-9 (55106-9)

Active Ingredient (in each softgel)

Simethicone 180 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:38.875834 · Updated: 2026-03-14T23:09:33.254922