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

Purpose

Purpose Anti-gas

Description

Active ingredient (in each softgel) Simethicone 125 mg


Medication Information

Purpose

Purpose

Anti-gas

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
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

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

Active Ingredient

Active ingredient (in each softgel)

Simethicone 125 mg

Questions Or Comments?

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


Structured Label Content

Purpose

Purpose

Anti-gas

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
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

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)

Warning

Warning

Active Ingredient (Active ingredient)

Active ingredient (in each softgel)

Simethicone 125 mg

Questions Or Comments? (Questions or comments?)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)