419- Anti Gas

419- Anti Gas
SPL v6
SPL
SPL Set ID 7731bd63-667e-4fed-b446-92a4a83b66d6
Route
ORAL
Published
Effective Date 2020-11-03
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 Glycerin Peppermint Oil Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-28

Description

Simethicone 125mg

Purpose

Anti gas


Medication Information

Purpose

Anti gas

Description

Simethicone 125mg

Use(s)

for the relief of 

  • pressure, bloating, and fullness commonly referred to as gas 
Storage
  • store at room temperature 20o-25oC (68-77oF)
  • protect from light, heat and moisture
Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

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
  • Do not use if blister unit is torn or open 
  • do not use if imprinted safety seal under cap is broken or missing
Active Ingredient(s)

Simethicone 125mg

Inactive Ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Principal Display Panel
Gas Relief

Structured Label Content

Use(s)

for the relief of 

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

Anti gas

Storage
  • store at room temperature 20o-25oC (68-77oF)
  • protect from light, heat and moisture
Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

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)
  • Do not use if blister unit is torn or open 
  • do not use if imprinted safety seal under cap is broken or missing
Active Ingredient(s) (Active ingredient(s))

Simethicone 125mg

Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Principal Display Panel
Gas Relief

Advanced Ingredient Data


Raw Label Data

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