cvs_721t_51316-621_simethicone soft gelatin capsules 180 mg

cvs_721t_51316-621_simethicone soft gelatin capsules 180 mg
SPL v2
SPL
SPL Set ID 24ceba32-eb30-902f-e063-6394a90a9fd5
Route
oral
Published
Effective Date 2025-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (180 mg)
Inactive Ingredients
shellac glycerin peppermint oil sorbitan fd&c yellow no. 6 medium-chain triglycerides sorbitol water propylene glycol titanium dioxide gelatin

Identifiers & Packaging

Pill Appearance
Imprint: 107 Shape: oval Color: orange Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-02-01

Description

Active ingredient (in each softgel) Simethicone 180 mg


Medication Information

Warnings and Precautions

​Warning

Active Ingredient

Active ingredient (in each softgel)

Simethicone 180 mg

Indications and Usage

Use for the relief of

  • pressure and bloating commonly referred to as gas.
Dosage and Administration

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Description

Active ingredient (in each softgel) Simethicone 180 mg

Section 50565-1

Keep out of reach of children.

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? Call 1-877-290-4008

Section 55105-1

Purpose

Anti-gas

Section 60561-8

Other information

  • store at room temperature
  • protect from light, heat and moisture

Structured Label Content

Warnings and Precautions (34071-1)

​Warning

Active Ingredient (55106-9)

Active ingredient (in each softgel)

Simethicone 180 mg

Indications and Usage (34067-9)

Use for the relief of

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

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Section 50565-1 (50565-1)

Keep out of reach of children.

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? Call 1-877-290-4008

Section 55105-1 (55105-1)

Purpose

Anti-gas

Section 60561-8 (60561-8)

Other information

  • store at room temperature
  • protect from light, heat and moisture

Advanced Ingredient Data


Raw Label Data

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