"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.
VICODIN HP (hydrocodone bitrate and acetaminophen tablets) Tablets are indicated for the relief of moderate to moderately severe pain.
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to severity of 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.
VICODIN HP® (hydrocodone bitrate and acetaminophen tablets) (hydrocodone bitartrate and acetaminophen, 10 mg/660 mg) is supplied as a white, oval-shaped, tablet bisected on one side and debossed with “VICODIN HP (hydrocodone bitrate and acetaminophen tablets) ” on the other side.
Bottles of 100-NDC #0074-2274-14
Bottles of 500-NDC #0074-2274-54
Storage: 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.
Revised March, 2007. Abbott Laboratories, North Chicago, IL 60064, USAThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/29/2009
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