"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.
Lorcet® 10/650, Hydrocodone Bitartrate and Acetaminophen Tablets, each tablet of which contains hydrocodone bitartrate 10 mg (WARNING:May be habit-forming) and acetaminophen 650 mg, are light-blue, capsule-shaped, scored tablets, debossed “UAD” on one side and “63 50” on the other side, and are supplied in containers of 100 tablets, NDC 0785-6350-01 and in containers of 500 tablets, NDC 0785-6350-50.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container, with a child-resistant closure.
Manufactured by: Mikart, Inc., Atlanta, GA 30318. Manufactured for: UAD Laboratories, Division of, Forest Pharmaceuticals, Inc., St. Louis, MO 63045. Rev. 01/08This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/25/2012
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