DESCRIPTION
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are supplied in tablet form for oral administration.

Each tablet contains:
Acetaminophenִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ712.8 mg
Caffeineִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִִ60 mg
Dihydrocodeine* bitartrateִִִִִִִִִִִִִִִִִִִִִִ32 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.=151.16

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

C8H10N4O2 M.W=194.19

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

C18H23NO3 C4H6O6 M.W.=451.47

In addition, each tablet also contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid.

CLINICAL PHARMACOLOGY:
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets contain dihydrocodeine which is a semisynthetic 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 persons with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or 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 P