Gas Relief Extra Strength: Package Insert and Label Information

GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled
Rite Aid Corporation

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.

In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away

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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

EXTRA STRENGTH

GAS RELIEF

SIMETHICONE125 mg

ANTIGAS

For Relief of:

pressure • bloating • discomfort

small, easy to swallow

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:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

Product Label

RITE AID Extra Strength Gas Relief

GAS RELIEF EXTRA STRENGTH simethicone capsule, liquid filled

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-4300 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:11822-4300-8 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 (11822-4300-8)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/31/2020

Labeler — Rite Aid Corporation (014578892)

Revised: 12/2022 Rite Aid Corporation