Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of BUNAVAIL. For more information, ask your doctor or pharmacist.

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

How should I store BUNAVAIL?

• Store BUNAVAIL at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep BUNAVAIL dry.
• Do not freeze BUNAVAIL.
• Do not use BUNAVAIL buccal film if the foil package has been damaged.
• Keep BUNAVAIL in a safe place, out of sight and reach of children.

How should I dispose of unused BUNAVAIL?

• Dispose of unused BUNAVAIL buccal film as soon as you no longer need them.
• Remove the unused BUNAVAIL buccal film from the foil packages.
• Drop the BUNAVAIL buccal films into the toilet and flush.
• Do not flush the BUNAVAIL foil packages or cartons down the toilet.

If you need help with disposal of BUNAVAIL, call 1-800-469-0261.

General information about the safe and effective use of BUNAVAIL.

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

This Medication Guide summarizes the most important information about BUNAVAIL. If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information that is written for health professionals.

For more information, call 1-800-469-0261.

What are the ingredients in BUNAVAIL?

Active ingredients: buprenorphine hydrochloride, naloxone hydrochloride dihydrate

Inactive ingredients: carboxymethylcellulose sodium, citric acid, citrus blend flavor, dibasic sodium phosphate, blue ink, hydroxyethyl cellulose, hydroxypropyl cellulose, methylparaben, monobasic sodium phosphate, polycarbophil, propylene glycol, propylparaben, yellow iron oxide, sodium benzoate, sodium hydroxide, sodium saccharin, vitamin E acetate, and purified water. Blue ink contains FD&C blue #1, ethanol, purified shellac, acetone, ammonium hydroxide and water.

Manufactured for:

BioDelivery Sciences International, Inc., Raleigh, North Carolina 27607 USA

BBF-001-MG

Issued: June 2014
biodelivery sciences
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•PRINCIPAL DISPLAY PANEL(What is this?)

PRINCIPAL DISPLAY PANEL - Bunavail 2 mg Pouch Label

•PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - Bunavail 2 mg Carton Label
•PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - Bunavail 4 mg Pouch Label
•PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - Bunavail 4 mg Carton Label
•PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - Bunavail 6 mg Pouch Label
•PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - Bunavail 6 mg Carton Label
•INGREDIENTS AND APPEARANCE
BUNAVAIL  buprenorphine and naloxone film
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59385-012
Route of Administration BUCCAL DEA Schedule CIII    
 
Act