Gas Relief Extra Strength: Package Insert and Label Information

GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

• for the relief of pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 physican

Other information

• store between 20-25°C (68-77°F)
• do not refrigerate
• protect from light, heat, and moisture

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

Call 1-800-616-2471

Principal Display Panel

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

Gas Relief

Simethicone 125 mg / Antigas

FAST RELIEF OF

PRESSURE • BLOATING • DISCOMFORT

EXTRA STRENGTH

SOFTGELS

†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X Extra Strength.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

MAJOR PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Product Label

MAJOR Gas Relief

GAS RELIEF EXTRA STRENGTH simethicone capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6994 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN GLYCERIN PEPPERMINT OIL WATER SORBITAN SORBITOL TITANIUM DIOXIDE MANNITOL

Product Characteristics Color green Score no score Shape OVAL Size 9mm Flavor Imprint Code PO Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0904-6994-46 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (0904-6994-46)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 06/30/2019

Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2022 Major Pharmaceuticals