Hydrocodone Bitartate and Acetaminophen (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets USP, contain hydrocodone bitartrate 5 mg and acetaminophen 325 mg. They are supplied as white with orange specks, capsule-shaped, bisected tablets, debossed WATSON on one side and 3202 on the other side, in bottles of 100 and 500.

Storage:

Store at controlled room temperature 15°-30°C (59°-86°F).

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

A Schedule CIII Narcotic.

Manufactured by:
Mikart, Inc.
Atlanta, GA 30318

Distributed by:
Watson Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. 08/2013
Code 667D00

Principal Display Panel

NDC 0591-3202-01
Hydrocodone
Bitartrate and
Acetaminophen
Tablets USP
5 mg/325 mg
Watson 100 Tablets Rx only

NDC 0591-3202-01 Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/ 325 mg Watson 100 Tablets Rx only
(click image for full-size original)

HYDROCODONE BITARTATE AND ACETAMINOPHEN
hydrocodone bitartate and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3202
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
STEARIC ACID
SUCROSE
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (specks) , WHITE Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code WATSON;3202
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-3202-01 100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:0591-3202-05 500 TABLET (500 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040099 06/25/1997
Labeler — Watson Laboratories, Inc. (106931488)
Establishment
Name Address ID/FEI Operations
Mikart, Inc. 013322387 MANUFACTURE (0591-3202)

Revised: 10/2013 Watson Laboratories, Inc.

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