722t_kroger_41226-722_simethicone Softgel 125mg

722t_kroger_41226-722_simethicone Softgel 125mg
SPL v3
SPL
SPL Set ID ea1c7b4c-91a1-0c1c-e053-2995a90ab823
Route
ORAL
Published
Effective Date 2023-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Medium-chain Triglycerides Peppermint Oil Propylene Glycol Shellac Sorbitol Solution Gelatin Glycerin Water Titanium Dioxide Fd&c Red No. 40 Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: 105 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-05

Description

Active ingredient (in each softgel) Simethicone 125 mg

Purpose

Purpose Anti-gas


Medication Information

Purpose

Purpose

Anti-gas

Description

Active ingredient (in each softgel) Simethicone 125 mg

Use

Use for the relief of

  • pressure, bloating and fullness commonly referred to as gas

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warning

Warning

Directions

Directions

  • adults and children 12 years and older: 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
Active Ingredient

Active ingredient (in each softgel)

Simethicone 125 mg

Other Information

Other information

  • store at room temperature
  • protect from light, heat and moistur e
Inactive Ingredients

Inactive ingredients

D&C Yellow 10, FD&C Red #40, FD&C Blue 1, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

Questions or comments? Call 1-800-632-6900


Structured Label Content

Use

Use for the relief of

  • pressure, bloating and fullness commonly referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Purpose

Anti-gas

Warning

Warning

Directions

Directions

  • adults and children 12 years and older: 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
Active Ingredient (Active ingredient)

Active ingredient (in each softgel)

Simethicone 125 mg

Other Information (Other information)

Other information

  • store at room temperature
  • protect from light, heat and moistur e
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

D&C Yellow 10, FD&C Red #40, FD&C Blue 1, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

Questions or comments? Call 1-800-632-6900


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)