Gas Relief

Gas Relief
SPL v1
SPL
SPL Set ID c8dd7fdd-9cf9-4e29-b1fa-12dbe9afd384
Route
ORAL
Published
Effective Date 2016-07-13
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

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-13

Description

Drug Facts

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Drug Facts

Uses

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas
Section 42229-5

Drug Facts

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 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
Inactive Ingredients

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

Questions Or Comments?

Call toll free: 1-800-833-6278

Principal Display Panel

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 30 Softgels

NDC 51013-109-10

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

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 50 Softgels

NDC 51013-109-09

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

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
Section 42229-5 (42229-5)

Drug Facts

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 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture
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

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-833-6278

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 30 Softgels

NDC 51013-109-10

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

EXTRA STRENGTH GAS RELIEF 

SIMETHICONE 125 mg ANTIGAS 50 Softgels

NDC 51013-109-09

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

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

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)