Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID a1a19ef7-4a14-4fcb-8917-631d867be0bb
Route
ORAL
Published
Effective Date 2021-02-24
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 Fd&c Red No. 40 Gelatin Type B Bovine (230 Bloom) Glycerin Peppermint Oil Titanium Dioxide Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: SCU Shape: oval Color: green Size: 10 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-02

Description

Simethicone 125mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125mg

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Directions
  • adults: 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
  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat, and moisture
Inactive Ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

800-935-2362

Principal Display Panel

Active Ingredient (in Each Softgel)

Simethicone 125mg


Structured Label Content

Use

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Purpose

Antigas

Directions
  • adults: 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 controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat, and moisture
Inactive Ingredients (Inactive ingredients)

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

800-935-2362

Principal Display Panel

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 125mg


Advanced Ingredient Data


Raw Label Data

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