Percocet, Page 3

Percocet, oxycodone hydrochloride and acetaminophen, is indicated for the relief of moderate to moderately severe pain. Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. PERCOCET tablets are given orally.

Percocet 2.5 mg/325 mg
The usual adult dosage is one or 2 tablets every 6 hours. The total daily dose of acetaminophen should not exceed 4 grams.

Percocet 5 mg/325 mg; Percocet 7.5 mg/500 mg; Percocet 10 mg/650 mg
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Percocet 7.5 mg/325 mg; Percocet 10 mg/325 mg
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Strength Maximal Daily Dose
Percocet 2.5 mg/325 mg 12 Tablets
Percocet 5 mg/325 mg 12 Tablets
Percocet 7.5 mg/325 mg 8 Tablets
Percocet 7.5 mg/500 mg 8 Tablets
Percocet 10 mg/325 mg 6 Tablets
Percocet 10 mg/650 mg 6 Tablets

Cessation of Therapy

In patients treated with PERCOCET 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

PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:

5 mg/325 mg
Blue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.

Bottles of 10
NDC 54868-0510-3
Bottles of 20
NDC 54868-0510-2
Bottles of 60
NDC 54868-0510-0
Bottles of 100
NDC 54868-0510-1

7.5 mg/325 mg
Peach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.

Bottles of 100
NDC 54868-4603-0

7.5 mg/500 mg
Orange, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.

Bottles of 100
NDC 54868-4574-0

10 mg/325 mg
Yellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.

Bottles of 60
NDC 54868-4710-1
Bottles of 100
NDC 54868-4710-0

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).

DEA Order Form Required.

Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317

PERCOCET® is a Registered Trademark of Endo Pharmaceuticals Inc.

Copyright © Endo Pharmaceuticals Inc. 2006

Printed in U.S.A. 2000055/November, 2006


Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

PERCOCET

(Oxycodone and Acetaminophen Tablets, USP)

Oxycodone Hydrochloride, USP 5 mg*
Acetaminophen, USP 325 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.

image of 5/325 mg package label
(click image for full-size original)

Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.

image of 7.5/325 mg package label
(click image for full-size original)

Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 500 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.

image of 7.5/500 mg package label
(click image for full-size original)

Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 325 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

image of 10/325 mg package label
(click image for full-size original)
PERCOCET
oxycodone hydrochloride and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0510(NDC:63481-623)
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
FD&C BLUE NO. 1
Product Characteristics
Color blue Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PERCOCET;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0510-0 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0510-1 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0510-2 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-0510-3 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040330 03/13/2000
PERCOCET
oxycodone hydrochloride and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4710(NDC:63481-629)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 10 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STEARIC ACID
STARCH, CORN
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code PERCOCET;10;325
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4710-0 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4710-1 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040434 12/02/2002
PERCOCET
oxycodone hydrochloride and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4603(NDC:63481-628)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 7.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color orange Score no score
Shape OVAL Size 14mm
Flavor Imprint Code PERCOCET;7;5;325
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4603-0 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040434 03/13/2002
PERCOCET
oxycodone hydrochloride and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4574(NDC:63481-621)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 7.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code PERCOCET;7;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4574-0 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040341 11/07/2001
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 02/2010 Physicians Total Care, Inc.

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