Dihydrocodeine Bitartrate, Acetaminophen and Caffeine (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The usual adult dosage is one (1) Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets 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 one (1) tablet should be taken in a 4-hour period. No more than five (5) doses, or five (5) tablets should be taken in a 24-hour period.

HOW SUPPLIED:

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming). 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

image of package label
(click image for full-size original)
DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AND CAFFEINE
dihydrocodeine bitartrate, acetaminophen and caffeine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5900(NDC:64376-611)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIHYDROCODEINE BITARTRATE (DIHYDROCODEINE) DIHYDROCODEINE BITARTRATE 32 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 712.8 mg
CAFFEINE (CAFFEINE) CAFFEINE 60 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code Boca;611
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5900-0 30 TABLET (TABLET) in 1 BOTTLE, 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

Revised: 11/2009 Physicians Total Care, Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.