BUPRENORPHINE AND NALOXONE- buprenorphine and naloxone tablet 
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MEDICATION GUIDE

Buprenorphine (byoo pre Nor feen) and Naloxone (nah LOX own) Sublingual Tablets, USP (CIII)

IMPORTANT:
Keep buprenorphine and naloxone sublingual tablets in a secure place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes buprenorphine and naloxone sublingual tablets, get emergency help or call 911 right away. Tell your healthcare provider if you are living in a household where there are small children.

What is the most important information I should know about buprenorphine and naloxone sublingual tablets?

Buprenorphine and naloxone sublingual tablets may cause serious and life‐threatening breathing problems. Get emergency help right away if you:

  • feel faint
  • have blurred vision
  • feel dizzy
  • have slurred speech
  • are confused
  • are breathing slower than normal
  • feel sleepy or uncoordinated
  • cannot think well or clearly

What are buprenorphine and naloxone sublingual tablets?

Who should not take buprenorphine and naloxone sublingual tablets?

Do not take buprenorphine and naloxone sublingual tablets if you are allergic to buprenorphine or naloxone.

Before taking buprenorphine and naloxone sublingual tablets, tell your healthcare provider about all of your medical conditions, including if you have:

  • trouble breathing or lung problems
  • an enlarged prostate (men)
  • a head injury or brain problem
  • a curve in your spine that affects your breathing
  • problems urinating
  • mental health problems
  • Addison's disease
  • liver, kidney, or gallbladder problems
  • adrenal gland or thyroid gland problems
  • alcoholism
  • tooth problems, including a history of cavities

Tell your healthcare provider if you are:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

How should I take buprenorphine and naloxone sublingual tablets?

Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to take buprenorphine and naloxone sublingual tablets.

What should I avoid while taking buprenorphine and naloxone sublingual tablets?

What are the possible side effects of buprenorphine and naloxone sublingual tablets?

Buprenorphine and naloxone sublingual tablets can cause serious side effects, including:

These are not all the possible side effects of buprenorphine and naloxone sublingual tablets.

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

General information about the safe and effective use of buprenorphine and naloxone sublingual tablets.

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

You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information call Rhodes Pharmaceuticals at 1-888-827-0616.

What are the ingredients in Buprenorphine and Naloxone Sublingual Tablets, USP?

Active Ingredients: buprenorphine and naloxone

Inactive Ingredients: lactose monohydrate, povidone K29/32, acesulfame potassium, FD&C Yellow No.6 aluminum lake, natural lemon flavor 717297 (corn syrup solids, maltodextrin, modified starch, natural flavorings, tocopherol), citric acid anhydrous, trisodium citrate dihydrate, corn starch, mannitol, and magnesium stearate.

Manufactured by:
Purdue Pharma L.P.
Stamford, CT 06901

Marketed by:
Rhodes Pharmaceuticals
Wilson, NC 27893

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

Revised: 4/2023

Revised: 3/2024
Bryant Ranch Prepack