CARBAMAZEPINE tablet, extended release CARBAMAZEPIN- carbamazepine tablet, extended release

Carbamazepine by

Drug Labeling and Warnings

Carbamazepine by is a Prescription medication manufactured, distributed, or labeled by Upsher-Smith Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

How can I watch for early symptoms of suicidal thoughts and actions?

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop carbamazepine extended-release tablets without first talking to a healthcare provider.

Stopping carbamazepine extended-release tablets suddenly can cause serious problems. You should talk to your healthcare provider before stopping.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What are carbamazepine extended-release tablets?

Carbamazepine extended-release tablets are a prescription medicine used to treat:

Carbamazepine extended-release tablets are not a regular pain medicine and should not be used for aches or pains.

Who should not take carbamazepine extended-release tablets?

Do not take carbamazepine extended-release tablets if you:

What should I tell my healthcare provider before taking carbamazepine extended-release tablets?

Before you take carbamazepine extended-release tablets, tell your healthcare provider if you:

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

Taking carbamazepine extended-release tablets with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take carbamazepine extended-release tablets?

What should I avoid while taking carbamazepine extended-release tablets?

What are the possible side effects of carbamazepine extended-release tablets?

See "What is the most important information I should know about carbamazepine extended-release tablets?"

Carbamazepine extended-release tablets may cause other serious side effects. These include:

Get medical help right away if you have any of the symptoms listed above or listed in "What is the most important information I should know about carbamazepine extended-release tablets?"

The most common side effects of carbamazepine extended-release tablets include:

These are not all the possible side effects of carbamazepine extended-release tablets. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 carbamazepine extended-release tablets?

Store carbamazepine extended-release tablets at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Keep carbamazepine extended-release tablets and all medicines out of the reach of children.

General Information about carbamazepine extended-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use carbamazepine extended-release tablets for a condition for which it was not prescribed. Do not give carbamazepine extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about carbamazepine extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about carbamazepine extended-release tablets that is written for health professionals.

What are the ingredients in carbamazepine extended-release tablets?

Active ingredient: carbamazepine, USP

Inactive ingredients: cellulose acetate, dextrates, ferric oxide red, hydroxyethyl cellulose, hypromellose, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac glaze.

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

For Medication Guides, please visit www.upsher-smith.com or call 1-888-650-3789.

Made in China

Distributed by
UPSHER-SMITH LABORATORIES. LLC
Maple Grove, MN 55369

Revised: 8/2020

  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

    NDC: 0832-6022-11

    Carbamazepine Extended-Release
    Tablets, USP

    100 mg

    Carbamazepine extended-release tablets must be
    swallowed whole and never crushed or chewed.

    PHARMACIST: Dispense the Medication
    Guide provided separately to each patient.

    100 Tablets
    Rx only

    UPSHER-SMITH

    CSPC

    PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

    NDC: 0832-6023-11

    Carbamazepine Extended-Release
    Tablets, USP

    200 mg

    Carbamazepine extended-release tablets must be
    swallowed whole and never crushed or chewed.

    PHARMACIST: Dispense the Medication
    Guide provided separately to each patient.

    100 Tablets
    Rx only

    UPSHER-SMITH

    CSPC

    PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
  • PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

    NDC: 0832-6024-11

    Carbamazepine Extended-Release
    Tablets, USP

    400 mg

    Carbamazepine extended-release tablets must be swallowed whole
    and never crushed or chewed.

    PHARMACIST: Dispense the Medication
    Guide provided separately to each patient.

    100 Tablets
    Rx only

    UPSHER-SMITH

    CSPC

    PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    CARBAMAZEPINE 
    carbamazepine tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0832-6022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M) Carbamazepine100 mg
    Inactive Ingredients
    Ingredient NameStrength
    cellulose acetate (UNII: 3J2P07GVB6)  
    dextrates (UNII: G263MI44RU)  
    ferric oxide red (UNII: 1K09F3G675)  
    hydroxyethyl cellulose, unspecified (UNII: T4V6TWG28D)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ammonia (UNII: 5138Q19F1X)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    Product Characteristics
    ColorWHITE (pinkish white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code B28
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0832-6022-11100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21331104/13/2021
    CARBAMAZEPIN 
    carbamazepine tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0832-6023
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M) Carbamazepine200 mg
    Inactive Ingredients
    Ingredient NameStrength
    cellulose acetate (UNII: 3J2P07GVB6)  
    dextrates (UNII: G263MI44RU)  
    ferric oxide red (UNII: 1K09F3G675)  
    hydroxyethyl cellulose, unspecified (UNII: T4V6TWG28D)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ammonia (UNII: 5138Q19F1X)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    Product Characteristics
    ColorWHITE (pinkish white) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code B29
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0832-6023-11100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21331104/13/2021
    CARBAMAZEPINE 
    carbamazepine tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0832-6024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M) Carbamazepine400 mg
    Inactive Ingredients
    Ingredient NameStrength
    cellulose acetate (UNII: 3J2P07GVB6)  
    dextrates (UNII: G263MI44RU)  
    ferric oxide red (UNII: 1K09F3G675)  
    hydroxyethyl cellulose, unspecified (UNII: T4V6TWG28D)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ammonia (UNII: 5138Q19F1X)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    Product Characteristics
    ColorWHITE (pinkish white) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code B30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0832-6024-11100 in 1 BOTTLE; Type 0: Not a Combination Product04/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21331104/13/2021
    Labeler - Upsher-Smith Laboratories, LLC (809088862)

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