"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 severity of pain and 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.
Lortab ® 10/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg) contain hydrocodone bitartrate 10 mg and acetaminophen 500 mg. They are supplied as pink, capsule-shaped, bisected tablets, debossed "ucb" on one side and "910" on the other side, in containers of 100 tablets NDC 50474-910-01, 500 tablets NDC 50474-910-50, and in hospital unit-dose packages of 100 tablets [4 X 25] NDC 50474- 910-60.
STORAGE: 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.
A Schedule CIII Narcotic
Manufactured for: UCB Pharma, Inc. Smyrna, GA 30080. Manufactured by: Mallinckrodt Inc.Hobart, New York 13788. Rev. 03/2004. FDA rev date: 8/3/2000This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2008
Additional Lortab 10 Information
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