DOSAGE AND ADMINISTRATION:
The usual adult dosage is two (2) TREZIX™ capsules orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than two (2) capsules should be taken in a 4-hour period. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.

HOW SUPPLIED:
TREZIX™ capsules, containing acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine* bitartrate 16 mg (*Warning: May be habit-forming), are supplied in bottles of 100 capsules (NDC #66992-340-10).
Also, TREZIX™ is supplied in single-capsule sample blister packs (NDC #66992-340-01).
Capsules are imprinted “TREZIX” on the red cap in white ink.

Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture.

Rx Only

Manufactured for:
WraSer Pharmaceuticals LLC
Ridgeland, MS 39157

13001 Rev. May 2011

Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.

WraSerTM
PHARMACEUTICALS

NDC 66992-340-10

TREZIX® CIII

(acetaminophen, caffeine and dihydrocodeine*
bitartrate capsules 320.5mg/30mg/16mg)

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.

Rx ONLY

*WARNING: May be habit-forming.

100 CAPSULES

TREZIX
acetaminophen, caffeine, dihydrocodeine bitartrate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66992-340
Route of Administration ORAL DEA Schedule CIII 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN)  ACETAMINOPHEN 320.5mg
CAFFEINE (CAFFEINE)  CAFFEINE 30mg
DIHYDROCODEINE BITARTRATE (DIHYDROCODEINE)  DIHYDROCODEINE BITARTRATE 16mg
 
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE 
MAGNESIUM STEARATE 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
 
Product Characteristics
Color red Score no score 
Shape CAPSULE Size 20mm
Flavor  Imprint Code TREZIX 
Contains 
 
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66992-340-10 100 CAPSULE ( CAPSULE) in 1 BOTTLE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040688 09/01/2009 

Labeler -WraSer LLC (121828334)