Hydrocodone Bitartrate and Acetaminophen Tablets (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 tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets.

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg / 500 mg are supplied as white to off-white, scored, oblong biconvex tablets, debossed “IP 112” on obverse and bisected on the reverse.

They are available as follows:

Bottles of 100: NDC 53746-112-01

Bottles of 500: NDC 53746-112-05

Bottles of 1000: NDC 53746-112-10

Storage: 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.

A Schedule CIII Narcotic.

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY 11788

Rev. 03-2011

copy of label

copy of label
(click image for full-size original)

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS
hydrocodone bitartrate and acetaminophen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-0492(NDC:53746-112)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 7.5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (off-white) Score 2 pieces
Shape CAPSULE (biconvex) Size 17mm
Flavor Imprint Code IP;112
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-0492-1 6 TABLET (TABLET) in 1 BOTTLE None
2 NDC:67296-0492-2 15 TABLET (TABLET) in 1 BOTTLE None
3 NDC:67296-0492-3 20 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040748 02/18/2010
Labeler — RedPharm Drug Inc. (008039641)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals 831227801 ANALYSIS, MANUFACTURE, LABEL, PACK

Revised: 05/2011 RedPharm Drug Inc.

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