Enulose (Page 2 of 2)

HOW SUPPLIED

Lactulose Solution USP, 10 g/15 ml, is a natural colored and an unflavored solution supplied in one pint (473 ml) bottles.

Lactulose solution, USP contains lactulose 670 mg/mL (10 g/15 mL).

Store between 36° to 86°F (2° to 30°C). Do not freeze.

Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use.

Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.

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

Manufactured and packaged by:
Fresenius Kabi Austria GmbH
Estermannstraße 17
4020 Linz Austria

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised — March 2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1
(click image for full-size original)

ENULOSE
lactulose solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-438
Route of Administration ORAL, RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTULOSE (LACTULOSE) LACTULOSE 10 g in 15 mL
Inactive Ingredients
Ingredient Name Strength
GALACTOSE
LACTOSE, UNSPECIFIED FORM
FRUCTOSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45963-438-64 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090502 02/28/2011
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 03/2016 Actavis Pharma, Inc.

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