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 12 tablets.

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5mg/325mg are supplied as white, capsule shaped, debossed “2.5/325” on one side and “KLE” on the other side, in bottles of 30 tablets, NDC 42254-300-30, bottles of 60 tablets, NDC 42254-300-60 and bottles of 90 tablets, NDC 42254-300-90.

Storage:

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

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

A Schedule CIII Narcotic

Rx Only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Manufactured for:

KLE 2, Inc.
Culver City, CA 90232

Repackage by:

REBEL DISTRIBUTORS, CORP.
Thousand Oaks, CA 91320

Principal Display Panel

Hydrocodone 2.5mg/325mg
(click image for full-size original)
HYDROCODONE BITARTATE AND ACETAMINOPHEN
hydrocodone bitartrate, acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-300(NDC:76218-1828)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 2.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white (WHITE) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 2;5;325;KLE
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-300-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:42254-300-60 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:42254-300-90 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040846 05/17/2012
Labeler — Rebel Distributors Corp (118802834)
Registrant — PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Operations
PSS World Medical, Inc. 791528623 REPACK (42254-300)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 REPACK (42254-300)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 RELABEL (42254-300), REPACK (42254-300)
Establishment
Name Address ID/FEI Operations
SCRIPT PAK 964420108 RELABEL (42254-300), REPACK (42254-300)
Establishment
Name Address ID/FEI Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK (42254-300)
Establishment
Name Address ID/FEI Operations
Rebel Distirbutors Corp. 118802834 RELABEL (42254-300), REPACK (42254-300)

Revised: 07/2012 Rebel Distributors Corp

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