Take DALIRESP exactly as your healthcare provider tells you to take it.
DALIRESP can be taken with or without food.
If you take more than your prescribed dose of DALIRESP, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of DALIRESP?

DALIRESP can cause serious side effects, including:

See “What is the most important information I should know about DALIRESP?”

The most common side effects of DALIRESP include:

diarrhea
weight loss
nausea
headache
back pain
flu like symptoms
problems sleeping (insomnia)
dizziness
decreased appetite
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of DALIRESP.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store DALIRESP Tablets?

Store DALIRESP at 68°F to 77°F (20°C to 25°C); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature].
Keep DALIRESP Tablets and all medicines out of the reach of children.

General information about DALIRESP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DALIRESP for a condition for which it was not prescribed. Do not give DALIRESP to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about DALIRESP. For more information about DALIRESP, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about DALIRESP that is written for health professionals.

For more information about DALIRESP call 1-800-678-1605.

What are the ingredients in DALIRESP?

Active ingredient: roflumilast
Inactive ingredients: lactose monohydrate, corn starch, povidone and magnesium stearate.

Rx only

Manufactured by:
Nycomed GmbH
Production Site Oranienburg
Lehnitzstrasse 70 – 98
16515 Oranienburg
Germany

Manufactured for:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045, USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rev. 02/2011

Principal Display Panel – 30 Tablets Bottle Label

Rx Only NDC 0456-0095-30

Daliresp™

(roflumilast) tablets

500 mcg per tablet

Dispense the accompanying Medication Guide to each patient

30 Tablets

FOREST PHARMACEUTICALS, INC.

Subsidiary of Forest Laboratories, Inc.

St. Louis, Missouri 63045

DALIRESP
roflumilast tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0456-0095
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
roflumilast(roflumilast) roflumilast 500ug
 
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate 
starch, corn 
povidone 
magnesium stearate 
 
Product Characteristics
Color white (wh