May 25, 2017
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Trezix

"A US Food and Drug Administration (FDA) advisory panel voted 15 to 5 Tuesday, recommending that the combination of an analgesic with antacids is not "a rational combination for over-the-counter (OTC) use for the relief of minor aches and pains as"...

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Trezix Capsules

TREZIX™
(acetaminophen, caffeine, dihydrocodeine bitartrate) Capsules

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.

DRUG DESCRIPTION

TREZIX™ capsules are supplied in capsule form for oral administration.
Each red capsule contains:

Acetaminophen 320.5 mg
Caffeine 30 mg
Dihydrocodeine* bitartrate 16 mg

*Warning: May Be Habit-Forming.

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

Acetaminophen - Structural Formula Illustration 1

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

Caffeine - Structural Formula Illustration 2

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

Dihydrocodeine bitartrate - Structural Formula Illustration 3

In addition, each capsule contains the following inactive ingredients: crospovidone, magnesium stearate, povidone, pregelatinized starch, stearic acid. The capsule is composed of FD&C Red #40, and gelatin. Imprinting ink is composed of ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, pharmaceutical glaze (modified) in SD-45, propylene glycol, simethicone, and titanium dioxide.

Last reviewed on RxList: 2/28/2017
This monograph has been modified to include the generic and brand name in many instances.

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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