"Jan. 28, 2013 -- It may become more difficult to get prescriptions for drugs containing hydrocodone combined with other pain relievers.
An FDA panel voted 17 to 10 in favor of reclassifying hydrocodone-containing compounds, such as Vico"...
- Patient Information:
Details with Side Effects
Lortab 5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/500 mg) are indicated for the relief of moderate to moderately severe pain.
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 or two tablets every four to six hours as needed for pain. The total daily dosage for adults should not exceed 8 tablets.
Lortab ® 5/500 tablets (Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/500 mg) contain hydrocodone bitartrate 5 mg and acetaminophen 500 mg. They are supplied as white with blue specks, capsule-shaped, bisected tablets, debossed "ucb" on one side and "902" on the other side, in containers of 100 tablets NDC 50474-902-01, 500 tablets NDC 50474-902-50, and in hospital unit-dose packages of 100 tablets [4 X 25] NDC 50474-902-60.
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, NY 13788. FDA rev date: 8/3/2000
Last reviewed on RxList: 1/30/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Lortab 5 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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