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

Purpose

Antigas

Description

Drug Facts


Medication Information

Warnings

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
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

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Questions Or Comments?

Call toll free: 1-800-833-6278

Active Ingredient (in Each Softgel)

Simethicone 125 mg


Structured Label Content

Warnings

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
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

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-833-6278

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

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)