Package Insert and Label Information: Monobasic Sodium Phosphate and Dibasic Sodium Phosphate (Page 3 of 3)

By Novel Laboratories, Inc. | Last revised: 20 January 2012

Page 3 of 3 « 1 2 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
monobasic sodium phosphate and dibasic sodium phosphate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:40032-030
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (SODIUM CATION)	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	1.105 g
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (SODIUM CATION)	SODIUM PHOSPHATE, DIBASIC ANHYDROUS	0.398 g

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 8000

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	OVAL (Modified)	Size	18mm
Flavor		Imprint Code	N;03
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:40032-030-01	100 TABLET (TABLET) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079247	01/20/2012

Labeler — Novel Laboratories, Inc. (793518643)

Registrant — Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, inc.		793518643	MANUFACTURE

Revised: 01/2012 Novel Laboratories, Inc.

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Clinical Trials

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FDA MedWatch
- West Coast Nutritionals Dietary Supplement Products: Recall – Undeclared Drug Ingredient
  Mon, 21 May 2012. Products marketed as dietary supplements contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
- Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
  Thu, 17 May 2012. A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug
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