BUPRENORPHINE: Package Insert and Label Information (Page 6 of 6)

INSTRUCTIONS FOR USE Buprenorphine (byoo-pre-NOR-feen) Sublingual Tablets, CIII

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

Important Information You Need to Know Before Taking Buprenorphine Sublingual Tablets:

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

Preparing to take Buprenorphine sublingual tablets:

  • Put the tablets under your tongue. Let them dissolve completely.
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  • While buprenorphine sublingual tablets are 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 sublingual tablets is absorbed.
  • After buprenorphine 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 sublingual tablets, 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 sublingual tablets 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 sublingual tablets the right way.

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

Storing buprenorphine sublingual tablets:

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

Disposing of buprenorphine sublingual tablets:

  • Dispose of unused buprenorphine sublingual tablets as soon as you no longer need them.
  • Dispose of expired, unwanted or unused buprenorphine 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 sublingual tablets, call Rhodes Pharmaceuticals L.P. at 1-888-827-0616.

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

Revised 06/2022

Buprenorphine SL 2mg (CIII) Tablet

Label
(click image for full-size original)
BUPRENORPHINE buprenorphine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0950(NDC:42858-501)
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE) BUPRENORPHINE 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
POVIDONE K30
ANHYDROUS CITRIC ACID
TRISODIUM CITRATE DIHYDRATE
STARCH, CORN
MANNITOL
CROSPOVIDONE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RP;b2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71335-0950-8 120 TABLET in 1 BOTTLE None
2 NDC:71335-0950-1 60 TABLET in 1 BOTTLE None
3 NDC:71335-0950-2 90 TABLET in 1 BOTTLE None
4 NDC:71335-0950-3 30 TABLET in 1 BOTTLE None
5 NDC:71335-0950-4 7 TABLET in 1 BOTTLE None
6 NDC:71335-0950-5 28 TABLET in 1 BOTTLE None
7 NDC:71335-0950-6 1 TABLET in 1 BOTTLE None
8 NDC:71335-0950-7 12 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207276 10/25/2017
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (71335-0950), RELABEL (71335-0950)

Revised: 09/2022 Bryant Ranch Prepack

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