g). Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in
Bottles of 30
NDC 54868-5900-0
Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight, light-resistant container with a child-resistant closure.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Rx Only
Manufactured for:
Boca Pharmacal, Inc.
Coral Springs, FL 33065
www.bocapharmacal.com
Rev. 06/09
Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Dihydrocodeine/Acetaminophen/Caffeine
32 mg/712.8 mg/60 mg
DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AND CAFFEINE
dihydrocodeine bitartrate, acetaminophen and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54868-5900(64376-611)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIHYDROCODEINE BITARTRATE(DIHYDROCODEINE) DIHYDROCODEINE BITARTRATE 32mg
ACETAMINOPHEN(ACETAMINOPHEN) ACETAMINOPHEN 712.8mg
CAFFEINE(CAFFEINE) CAFFEINE 60mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score 2pieces
Shape OVAL Size 19mm
Flavor Imprint Code Boca;611
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 54868-5900-0 30TABLETIn1BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040701 05/20/2008
Labeler -Physicians Total Care, Inc.(194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel,repack
