717t Albertsons 21130-717 Simethicone Soft Gelatin Capsules 180 Mg

717t Albertsons 21130-717 Simethicone Soft Gelatin Capsules 180 Mg
SPL v3
SPL
SPL Set ID eb4bef2c-15dd-434a-e053-2a95a90a616f
Route
ORAL
Published
Effective Date 2023-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (180 mg)
Inactive Ingredients
Sorbitan Sorbitol Solution Gelatin Titanium Dioxide Propylene Glycol Water Peppermint Oil Fd&c Yellow No. 6 Shellac Medium-chain Triglycerides Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: 104 Shape: oval Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-20

Description

Active ingredient (in each softgel) Simethicone 180 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • Relieves bloating, pressure or fullness commonly referred to as gas.
Dosage and Administration

Directions

• Swallow one or two softgels as symptoms occur.

• Do not exceed two softgels per 24 hours except under the advice and supervision of a physician.

Description

Active ingredient (in each softgel) Simethicone 180 mg

Section 44425-7

Other information

• Store at room temperature



Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if condition persists.

Section 51727-6

Inactive ingredients

FD&C Yellow No. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide





Section 51945-4

Section 53413-1

Questions or comments? 1-877-290-4008



Section 55105-1

Purpose

Anti-gas

Section 55106-9

Active ingredient (in each softgel)

Simethicone 180 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • Relieves bloating, pressure or fullness commonly referred to as gas.
Dosage and Administration (34068-7)

Directions

• Swallow one or two softgels as symptoms occur.

• Do not exceed two softgels per 24 hours except under the advice and supervision of a physician.

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

• Store at room temperature



Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition persists.

Section 51727-6 (51727-6)

Inactive ingredients

FD&C Yellow No. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide





Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-877-290-4008



Section 55105-1 (55105-1)

Purpose

Anti-gas

Section 55106-9 (55106-9)

Active ingredient (in each softgel)

Simethicone 180 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)