Rx only

Code 790Z00

Rev. 02/99

DESCRIPTION
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are supplied in tablet form for oral administration.

Each tablet contains:

Acetaminophen..........................................................712.8 mg

Caffeine.....................................................................60 mg

Dihydrocodeine Bitartrate*..........................................32 mg

(*Warning: May be habit forming)

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

C8H9NO2 M.W. = 151.17

Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

C8H10N4O2 (anhydrous)M.W. = 194.19

Dihydrocodeine bitartrate (4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

C18H23NO3•C4H6O6M.W. = 451.48

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, D&C Red #27 Aluminum Lake, D&C Red #30 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.

CLINICAL PHARMACOLOGY
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets contain dihydrocodeine which is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.

This combination product also contains acetaminophen, a non-opiate, non-salicylate analgesic, and antipyretic.

This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a central nervous system and cardiovascular stimulant.

INDICATIONS AND USAGE
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are indicated for the relief of moderate to moderately severe pain.

CONTRAINDICATIONS
This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or in any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

WARNINGS
Usage in Ambulatory Patients
Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Respiratory Depression
Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression occurs most frequently in elderly or debilitated patients, usually after large initial doses i