assured gas relief drug facts

assured gas relief drug facts
SPL v1
SPL
SPL Set ID d5b412b4-9121-42e0-8c3f-413810ade6dd
Route
oral
Published
Effective Date 2009-07-21
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 gelatin glycerin water titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: R113 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
otc monograph final active Since 2012-01-06

Purpose

Antigas

Description

Simethicone 125 mg


Medication Information

Uses

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
  • do not use if any individual blister unit is broken or missing
Other Information
  • store at controlled room temperature 20°-25°C (68-77°F)
  • protect from light, heat and moisture
Inactive Ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

Description

Simethicone 125 mg

Principal Display Panel

Compare to active ingredient in Extra Strength Gas-X®

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

Bloating, Pressure, Fullness, Gas

15 Softgels

Assured Gas Relief Extra Strength
Active Ingredient (in Each Softgel)

Simethicone 125 mg


Structured Label Content

Uses

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
  • do not use if any individual blister unit is broken or missing
Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68-77°F)
  • protect from light, heat and moisture
Inactive Ingredients (Inactive ingredients)

D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

Principal Display Panel

Compare to active ingredient in Extra Strength Gas-X®

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

Bloating, Pressure, Fullness, Gas

15 Softgels

Assured Gas Relief Extra Strength
Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

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