Oxycodone and Acetaminophen (Page 5 of 5)

Cessation of Therapy

In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

Oxycodone and Acetaminophen Tablets are supplied as follows:

5 mg/325 mg

Blue, round tablet, debossed with “ALV” and “196”, separated by a bisect, on one side, and plain on the other side.

10 TABLET in a BOTTLE (33261-196-10)
15 TABLET in a BOTTLE (33261-196-15)
20 TABLET in a BOTTLE (33261-196-20)
30 TABLET in a BOTTLE (33261-196-30)

Repackaged By

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

PRINCIPAL DISPLAY PANEL

SPL Image

OXYCODONE AND ACETAMINOPHEN oxycodone and acetaminophen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-196(NDC:47781-196) Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN POVIDONE LACTOSE MONOHYDRATE CROSPOVIDONE STEARIC ACID FD&C BLUE NO. 1

Product Characteristics Color BLUE Score 2 pieces Shape ROUND Size 11mm Flavor Imprint Code ALV;196 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:33261-196-10 10 TABLET in 1 BOTTLE None 2 NDC:33261-196-15 15 TABLET in 1 BOTTLE None 3 NDC:33261-196-20 20 TABLET in 1 BOTTLE None 4 NDC:33261-196-30 30 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202677 03/09/2016

Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 11/2016 Aidarex Pharmaceuticals LLC