OTC Medication Information: Antiflatulent

ANTIFLATULENT — dimethicone tablet, chewable
Aphena Pharma Solutions — Tennessee, LLC

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 tablet)

Simethicone 80 mg

PURPOSE

Antigas

USE(S)

relieves:

• pressure
• bloating
• symptoms referred to as gas

WARNINGS

.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
• do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

• do not use if inner seal is broken
• store at room temperature
• avoid high humidity and excessive heat, above 40^o C (104^o F)

HOW SUPPLIED

Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with “G and 103” on one side and are supplied as:

NDC 0904-7206-60 in bottle of 100 chewable tablets

Distributed by:

Major Pharmaceuticals

Livonia, MI 48152

INACTIVE INGREDIENTS

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

QUESTIONS

Call (800) 616-2471

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	80 mg
4	71610-650-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506
20220519JK

PRINCIPAL DISPLAY PANEL — 80 mg

NDC 71610-650 — Simethicone 80 mg Chewable Tablet — Rx Only

ANTIFLATULENT simethicone tablet, chewable

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-650(NDC:0904-7206) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg

Inactive Ingredients Ingredient Name Strength SUGARCANE MALTODEXTRIN DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SORBITOL

Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor PEPPERMINT Imprint Code G;103 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71610-650-04 4 TABLET, CHEWABLE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part332 10/04/2021

Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions — Tennessee, LLC		128385585	REPACK (71610-650)

Revised: 06/2022 Aphena Pharma Solutions — Tennessee, LLC