PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN (Page 5 of 5)

Storage and Dispensing

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

Inform patients of the availability of a Medication Guide for propoxyphene napsylate and acetaminophen tablets USP that accompanies each prescription dispensed. Instruct patients to read the propoxyphene napsylate and acetaminophen Medication Guide prior to using propoxyphene napsylate and acetaminophen tablets USP.

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

MEDICATION GUIDE

Ask your Pharmacist for a Medication Guide for Propoxyphene Napsylate and Acetaminophen Tablets, USP

Read the Medication Guide prior to using propoxphene napsylate and acetaminophen.

This information does not take the place of talking to your Doctor about your medical condition or your treatment.

A complete copy of the Medication Guide for Propoxyphene Napsylate and Acetaminophen Tablets, USP 100mg/650mg

is available upon request Call 1-800-262-5244

PACKAGE LABEL

NDC 12634-537-00

Propoxyphene Napsylate and Acetaminophen CIV

100mg/650mg

Bottle 10 Tablets

MFG: Teva Pharmaceuticals Inc.

Repackaged and Distributed:

Apotheca Inc.

image of label
(click image for full-size original)
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN propoxyphene napsylate and acetaminophen tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-537(NDC:0093-0890)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPOXYPHENE NAPSYLATE (PROPOXYPHENE) PROPOXYPHENE NAPSYLATE 100 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
D&C RED NO. 27
D&C YELLOW NO. 10
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
CROSPOVIDONE
Product Characteristics
Color pink (PINK) Score no score
Shape OVAL (OBLONG) Size 20mm
Flavor Imprint Code TEVA;890
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-537-91 1 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
2 NDC:12634-537-69 9 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
3 NDC:12634-537-55 15 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK None
4 NDC:12634-537-98 8 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:12634-537-00 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:12634-537-82 12 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
7 NDC:12634-537-85 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
8 NDC:12634-537-80 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
9 NDC:12634-537-71 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
10 NDC:12634-537-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
11 NDC:12634-537-01 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074119 01/01/2009
Labeler — Apotheca, Inc. (051457844)
Establishment
Name Address ID/FEI Operations
Apotheca, Inc. 051457844 relabel, repack

Revised: 03/2010 Apotheca, Inc.

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