Eliphos (Page 3 of 3)

HOW SUPPLIED

Product: 68151-5204

NDC: 68151-5204-0 1 TABLET in a PACKAGE

17 PATIENT COUNSELING INFORMATION

Inform patients to take ELIPHOS® with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after ELIPHOS®.

Manufactured for
Hawthorn Pharmaceuticals, Inc.
Morristown, NJ 07960
1-800-793-2145

HI257 08/15

Calcium Acetate

Label ImageLabel Image
ELIPHOS
calcium acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-5204(NDC:63717-910)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ACETATE (CALCIUM CATION) CALCIUM ACETATE 667 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 2mm
Flavor Imprint Code CYP910
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-5204-0 1 TABLET in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078502 02/01/2009
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-5204)

Revised: 08/2016 Carilion Materials Management

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