Buprenorphine (Page 11 of 11)

INSTRUCTIONS FOR USE

Buprenorphine ( bue” 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.
image
(click image for full-size original)
  • 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 are absorbed.

  • 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 many 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 1-888-838-2872.

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

Manufactured For:

Teva Pharmaceuticals

Parsippany, NJ 07054

Rev. A 8/2021

PRINCIPAL DISPLAY PANEL

NDC 0228-3156-03
Buprenorphine Sublingual Tablets 2 mg* CIII
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Children who accidentally take buprenorphine will need emergency medical care. Keep out of the reach of children.
Rx only30 Tablets

2mg new
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0228-3153-03
Buprenorphine Sublingual Tablets 8 mg* CIII
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Children who accidentally take buprenorphine will need emergency medical care. Keep out of the reach of children.
Rx only30 Tablets

8mgnew
(click image for full-size original)
BUPRENORPHINE buprenorphine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3156
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
ANHYDROUS CITRIC ACID
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
POVIDONE K30
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color orange Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 156
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-3156-03 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090819 02/19/2015
BUPRENORPHINE buprenorphine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3153
Route of Administration SUBLINGUAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE) BUPRENORPHINE 8 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
POVIDONE K30
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color orange Score no score
Shape OVAL Size 14mm
Flavor Imprint Code 153
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-3153-03 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090819 02/19/2015
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 08/2021 Actavis Pharma, Inc.

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