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Cessation of Therapy
In patients treated with PERCODAN (aspirin and oxycodone hydrochloride) 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
PERCODAN (Oxycodone and Aspirin Tablets, USP), tablets are supplied as a yellow round tablet, scored and debossed with "PERCODAN (aspirin and oxycodone hydrochloride) " on one side and plain on the other side. Available in:
Bottles of 100....................NDC 63481 -121 -70
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°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).
DEA Order Form Required.
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DESCRIPTION
Each PERCODAN (aspirin and oxycodone hydrochloride) Tablet contains:
Oxycodone Hydrochloride, USP...............4.8355 mg* Aspirin, USP............................................325 mg
PERCODAN (aspirin and oxycodone hydrochloride) Tablets also contain the following inactive ingredients: D&C Yellow 10, FD&C Yellow 6, microcrystalline cellulose and corn starch.
The oxycodone hydrochloride component is Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5a)-., a white to off-white, hygroscopic crystals or powder, odorless, soluble in water; slightly soluble in alcohol and is represented by the following structural formula:
C
18
H
21
NO
4
•HCl.........................MW 351.82
The aspirin component is 2-(acetyloxy)-, Benzoic acid, a white crystal, commonly tabular or needle-like, or white, crystalline powder. Is odorless or has a faint odor. Is stable in dry air; in moist air it gradually hydrolyzes to salicylic and acetic acids. Slightly soluble in water; freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether and is represented by the following structural formula:
C
9
H
8
O
4
.....................MW 180.16
*4.8355 mg oxycodone HC1 is equivalent to 4.3346 mg of Oxycodone as the free base.
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