3948c0e5-4ee7-5443-e063-6294a90ad6ae

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

Active Ingredient

Active Ingredient (in each softgel)

Simethicone 180 mg

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


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active Ingredient (in each softgel)

Simethicone 180 mg

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.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)