Prescription Drug Information: Buprenorphine HCl and Naloxone HCl (Page 10 of 10)

INSTRUCTIONS FOR USE

BUPRENORPHINE (bue” pre nor’ feen) AND NALOXONE (nal ox’ one) Sublingual Tablets, USP (CIII)

This “Instructions for Use” contains information on how to correctly take buprenorphine and naloxone sublingual tablets.

Important Information You Need to Know Before Taking buprenorphine and naloxone sublingual tablets:

  • Your healthcare provider should show you how to take buprenorphine and naloxone sublingual tablets the right way.

    Preparing to take buprenorphine and naloxone sublingual tablets:

  • Put the tablets under your tongue. Let them dissolve completely.
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  • While buprenorphine and naloxone sublingual tablet is dissolving, do not chew or swallow the tablet because the medicine will not work as well.
  • Talking while the tablet is dissolving can affect how well the medicine in buprenorphine and naloxone sublingual tablet is absorbed.
  • After buprenorphine and naloxone sublingual tablet is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.
  • If you miss a dose of buprenorphine and naloxone sublingual tablet, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
  • Do not stop taking buprenorphine and naloxone sublingual tablet suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your healthcare provider how to stop using buprenorphine and naloxone sublingual tablet the right way.

If you take too much buprenorphine and naloxone sublingual tablet or overdose, call Poison Control or get emergency medical help right away.

Storing buprenorphine and naloxone sublingual tablets:

  • Store buprenorphine and naloxone sublingual tablets at room temperature between 68° to 77°F (20° to 25°C).
  • Keep buprenorphine and naloxone sublingual tablets in a safe place, out of the sight and reach of children.

Disposing of buprenorphine and naloxone sublingual tablets:

  • Dispose of unused buprenorphine and naloxone sublingual tablets as soon as you no longer need them.
  • Dispose of expired, unwanted or unused buprenorphine and naloxone sublingual tablets by promptly flushing down the toilet (if a drug take‐back option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

If you need help with disposal of buprenorphine and naloxone sublingual tablet, call 1‐877‐835‐5472.

Manufactured by:
Amneal Pharmaceuticals of New York, LLC
Brookhaven, NY 11719

Distributed by:
Amneal Pharmaceuticals LLC Glasgow, KY 42141

Rev. 03-2022-01

This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

Buprenorphine/Naloxone (CIII) 2/0.5mg Tab

Label
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BUPRENORPHINE HCL AND NALOXONE HCL buprenorphine and naloxone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1514(NDC:65162-416)
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE) BUPRENORPHINE 2 mg
NALOXONE HYDROCHLORIDE DIHYDRATE (NALOXONE) NALOXONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
POVIDONE, UNSPECIFIED
SODIUM CITRATE, UNSPECIFIED FORM
STARCH, CORN
Product Characteristics
Color orange Score no score
Shape ROUND Size 6mm
Flavor Imprint Code A;14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-1514-1 30 TABLET in 1 BOTTLE None
2 NDC:71335-1514-2 10 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203136 02/22/2013
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-1514), RELABEL (71335-1514)

Revised: 09/2022 Bryant Ranch Prepack

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