Gas Relief Extra Strength: Package Insert and Label Information

GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled
EQUALINE (SuperValu)

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 toll free 1-855-423-2630

Principal Display Panel

Compare to Gas-X® Extra Strength active ingredient†

extra strength

gas relief

simethicone 125 mg

(antigas)

relief of

• bloating
• pressure
• discomfort

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 UNFI

PROVIDENCE, RI 02908 USA

Product Label

EQUALINE Extra strength Gas Relief

GAS RELIEF EXTRA STRENGTH simethicone capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-597 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:41163-597-30 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 (41163-597-30) 2 NDC:41163-597-50 50 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (41163-597-50)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/29/2019

Labeler — EQUALINE (SuperValu) (006961411)

Revised: 12/2022 EQUALINE (SuperValu)