Ultra Strength Gas Relief

Ultra Strength Gas Relief
SPL v2
SPL
SPL Set ID 206d57ec-c854-496e-af53-7d8b2a208d85
Route
ORAL
Published
Effective Date 2017-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (180 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance
Imprint: PC3 Shape: capsule Color: orange Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-24

Description

Simethicone 180 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 180 mg

Use

 for the relief of

  • pressure and bloating commonly referred to as gas
Section 50565-1

Keep out of reach of children

Warnings

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours under the advice and supervision of a physician
Other Information
  • store at controlled room temperature 15º - 30ºC (59º - 86ºF)
  • protect from heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white ink

Questions Or Comments?

Call toll free: 1-888-287-1915

Principal Display Panel

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas  50 Softgels

NDC 49035-585-21

*Compare to the active ingredient in Gas-X ®Ultra Strength

Active Ingredient (in Each Softgel)

Simethicone 180 mg


Structured Label Content

Use

 for the relief of

  • pressure and bloating commonly referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

Antigas

Warnings

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 2 softgels in 24 hours under the advice and supervision of a physician
Other Information (Other information)
  • store at controlled room temperature 15º - 30ºC (59º - 86ºF)
  • protect from heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

FD&C yellow#6, gelatin, glycerin, purified water and white ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-888-287-1915

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ultra Strength Gas Relief

Simethicone 180 mg Anti-gas  50 Softgels

NDC 49035-585-21

*Compare to the active ingredient in Gas-X ®Ultra Strength

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

Simethicone 180 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)