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COUMADIN- warfarin sodium tablet


  1. Advise Patients To:
  2. Do Not Take Coumadin If:
  3. Coumadin May Cause Serious Side Effects Including:
  4. How Should I Store Coumadin?
  5. Active Ingredient:
  6. Inactive Ingredients:
  7. Patient Information
  8. Before You Take Coumadin, Tell Your Healthcare Provider If You:
  9. How Should I Take Coumadin?
  10. What Should I Avoid While Taking Coumadin?
  11. What Are The Ingredients In Coumadin?
  12. Inactive Ingredients: Lactose, Starch, And Magnesium Stearate. The Following Tablets Contain:
  13. 2-1/2 Mg:
  14. 7-1/2 Mg:
  15. Revised: 11/2012document Id:

Advise Patients To: 

  • Strictly adhere to the prescribed dosage schedule [

    COUMADIN can cause bleeding which can be serious and sometimes lead to death. This is because COUMADIN is a blood thinner medicine that lowers the chance of blood clots forming in your body.

    • You may have a higher risk of bleeding if you take COUMADIN and:
      • are 65 years of age or older
      • have a history of stomach or intestinal bleeding
      • have high blood pressure (hypertension)
      • have a history of stroke, or mini-stroke (transient ischemic attack or TIA)
      • have serious heart disease
      • have a low blood count or cancer
      • have had trauma, such as an accident or surgery
      • have kidney problems
      • take other medicines that increase your risk of bleeding, including:
        • a medicine that contains heparin
        • other medicines to prevent or treat blood clots
        • nonsteroidal anti-inflammatory drugs (NSAIDs)
      • take warfarin sodium for a long time. Warfarin sodium is the active ingredient in COUMADIN.

    Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above.

    Many other medicines can interact with COUMADIN and affect the dose you need or increase COUMADIN side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider.

    Do not take other medicines that contain warfarin sodium while taking COUMADIN.

    • Get your regular blood test to check for your response to COUMADIN.This blood test is called an INR test. The INR test checks to

      COUMADIN is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs.

Do Not Take Coumadin If: 

  • your risk of having bleeding problems is higher than the possible benefit of treatment.Your healthcare provider will decide if COUMADIN is right for you.
  • you are pregnant unless you have a mechanical heart valve.COUMADIN may cause birth defects, miscarriage, or death of your unborn baby.
  • you are allergic to warfarin or any of the other ingredients in COUMADIN.
    Your healthcare provider will do a pregnancy test before you start treatment with COUMADIN. Females who can become pregnant should use effective birth control during treatment, and for at least 1 month after the last dose of COUMADIN.
  • are breastfeeding. You and your healthcare provider should decide if you will take COUMADIN and breastfeed. Check your baby for bruising or bleeding if you take COUMADIN and breastfeed.

Tell all of your healthcare providers and dentists that you are taking COUMADIN. They should talk to the healthcare provider who prescribed COUMADIN for you before you haveanysurgery or dental procedure. Your COUMADIN may need to be stopped for a short time or you may need your dose adjusted.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way COUMADIN works. Certain medicines may increase your risk of bleeding.

Coumadin May Cause Serious Side Effects Including: 

  • Death of skin tissue (skin necrosis or gangrene).This can happen soon after starting COUMADIN. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
  • Kidney problems.Kidney injury may happen in people who take COUMADIN. Tell your healthcare provider right away if you develop blood in your urine.Your healthcare provider may do tests more often during treatment with COUMADIN to check for bleeding if you already have kidney problems.
  • Purple toes syndrome.Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.

These are not all of the side effects of COUMADIN. For more information, ask your healthcare provider or pharmacist. 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 Coumadin? 

  • Store COUMADIN at room temperature between 68 F to 77 F (20 C to 25 C).
  • Keep COUMADIN in a tightly closed container
  • Keep COUMADIN out of the light and moisture.
  • Follow your healthcare provider or pharmacist instructions about the right way to throw away outdated or unused COUMADIN.
  • Females who are pregnant should not handle crushed or broken COUMADIN tablets.

Keep COUMADIN and all medicines out of the reach of children.

General information about the safe and effective use of COUMADIN.

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

You can ask your healthcare provider or pharmacist for information about COUMADIN that is written for health professionals.

Active Ingredient: 

warfarin sodium

Inactive Ingredients: 

lactose, starch, and magnesium stearate, in addition:

1 mg:

D&C Red No. 6 Barium Lake

2 mg:

FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake

2.5 mg:

D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake

3 mg:

FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake

4 mg:

FD&C Blue No. 1 Aluminum Lake

5 mg:

FD&C Yellow No. 6 Aluminum Lake

6 mg:

FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake

7.5 mg:

D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake

10 mg

Dye-free

COUMADIN is distributed by: Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA
COUMADINis a registered trademark of Bristol-Myers Squibb Pharma Company.

For more information, go to www.coumadin.com or call 1 800-321-1335.

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


Revised 08/2017

[print code]

Patient Information 

COUMADIN can cause bleeding which can be serious and sometimes lead to death. This is because COUMADIN is a blood thinner medicine that lowers the chance of blood clots forming in your body.

  • You may have a higher risk of bleeding if you take COUMADIN and:
    • are 65 years of age or older
    • have a history of stomach or intestinal bleeding
    • have high blood pressure (hypertension)
    • have a history of stroke, or "mini-stroke" (transient ischemic attack or TIA)
    • have serious heart disease
    • have a low blood count or cancer
    • have had trauma, such as an accident or surgery
    • have kidney problems
    • take other medicines that increase your risk of bleeding, including:
      • a medicine that contains heparin
      • other medicines to prevent or treat blood clots
      • nonsteroidal anti-inflammatory drugs (NSAIDs)
    • take warfarin sodium for a long time. Warfarin sodium is the active ingredient in COUMADIN.

Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above.

Many other medicines can interact with COUMADIN and affect the dose you need or increase COUMADIN side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider.

Do not take other medicines that contain warfarin sodium while taking COUMADIN.

  • Get your regular blood test to check for your response to COUMADIN.This blood test is called an INR test. The INR test checks to

    COUMADIN is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs.

    It is not known if COUMADIN is safe and effective in children.

Before You Take Coumadin, Tell Your Healthcare Provider If You: 

  • have bleeding problems
  • fall often
  • have liver or kidney problems
  • have high blood pressure
  • have a heart problem called congestive heart failure
  • have diabetes
  • plan to have any surgery or a dental procedure
  • have any other medical conditions
  • are pregnant or plan to become pregnant. "
  • are breast-feeding. You and your healthcare provider should decide if you will take COUMADIN and breast-feed.

Tell all of your healthcare providers and dentists that you are taking COUMADIN. They should talk to the healthcare provider who prescribed COUMADIN for you before you haveanysurgery or dental procedure. Your COUMADIN may need to be stopped for a short time or you may need your dose adjusted.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way COUMADIN works. Certain medicines may increase your risk of bleeding. "

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

How Should I Take Coumadin? 

  • Take COUMADIN exactly as prescribed.Your healthcare provider will adjust your dose from time to time depending on your response to COUMADIN.
  • You must have regular blood tests and visits with your healthcare provider to monitor your condition.
  • If you miss a dose of COUMADIN, call your healthcare provider.Take the dose as soon as possible on the same day.Do nottake a double dose of COUMADIN the next day to make up for a missed dose.
  • Call your healthcare provider right away if you:
    • take too much COUMADIN
    • are sick with diarrhea, an infection, or have a fever
    • fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you

What Should I Avoid While Taking Coumadin? 

  • Do not do any activity or sport that may cause a serious injury.

What Are The Ingredients In Coumadin? 

Active ingredient: Warfarin Sodium

Inactive Ingredients: Lactose, Starch, And Magnesium Stearate. The Following Tablets Contain: 

1 mg:D&C Red No. 6 Barium Lake
2 mg:FD&C Blue No. 2 Aluminum Lake and
FD&C Red No. 40 Aluminum Lake

2-1/2 Mg: 

D&C Yellow No. 10 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake3 mg:FD&C Yellow No. 6 Aluminum Lake,
FD&C Blue No. 2 Aluminum Lake, and
FD&C Red No. 40 Aluminum Lake4 mg:FD&C Blue No. 1 Aluminum Lake5 mg:FD&C Yellow No. 6 Aluminum Lake6 mg:FD&C Yellow No. 6 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake

7-1/2 Mg: 

D&C Yellow No. 10 Aluminum Lake and
FD&C Yellow No. 6 Aluminum Lake

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



COUMADIN is distributed by:
Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA

COUMADINis a registered trademark of Bristol-Myers Squibb Pharma Company.

**The brands listed (other than COUMADIN) are registered trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.


1258498A3 / 1215385A4 / 1205734A4 / 1205736A4
Rev October 2011

-------------------------------------------------------
REPRESENTATIVE PACKAGING

SeeHow Suppliedsection for a complete list of available packages of COUMADIN.


1 mg Rx only
COUMADIN
(Warfarin Sodium Tablets, USP)
Crystalline*
DISPENSE WITH MEDICATION GUIDE
HIGHLY POTENT ANTICOAGULANT
WARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.
DOSAGE: See package insert.

COUMADIN 1 mg Tablets


4 mg Rx only
COUMADIN
(Warfarin Sodium Tablets, USP)
Crystalline*
DISPENSE WITH MEDICATION GUIDE
HIGHLY POTENT ANTICOAGULANT
WARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.
DOSAGE: See package insert.

COUMADIN 4 mg Tablets


5 mg Rx only
COUMADIN
(Warfarin Sodium Tablets, USP)
Crystalline*
DISPENSE WITH MEDICATION GUIDE
HIGHLY POTENT ANTICOAGULANT
WARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.
DOSAGE: See package insert.

COUMADIN 5 mg Tablets


6 mg Rx only
COUMADIN
(Warfarin Sodium Tablets, USP)
Crystalline*
DISPENSE WITH MEDICATION GUIDE
HIGHLY POTENT ANTICOAGULANT
WARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.
DOSAGE: See package insert.

COUMADIN 6 mg Tablets


7 mg Rx only
COUMADIN
(Warfarin Sodium Tablets, USP)
Crystalline*
DISPENSE WITH MEDICATION GUIDE
HIGHLY POTENT ANTICOAGULANT
WARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.
DOSAGE: See package insert.

COUMADIN 7.5 mg Tablets
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-2128(NDC:0056-0169)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium1 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
D&C Red No. 6(UNII: 481744AI4O)
barium sulfate(UNII: 25BB7EKE2E)
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code1;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2128-010 in 1 BOTTLE
2NDC:54868-2128-230 in 1 BOTTLE
3NDC:54868-2128-390 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921809/27/2004
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-2129(NDC:0056-0170)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium2 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
FD&C Blue No. 2(UNII: L06K8R7DQK)
FD&C Red No. 40(UNII: WZB9127XOA)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorPURPLE (Lavender)Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code2;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2129-060 in 1 BOTTLE
2NDC:54868-2129-1100 in 1 BOTTLE
3NDC:54868-2129-230 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921803/25/200206/30/2012
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-2154(NDC:0056-0176)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium2.5 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
D&C Yellow No. 10(UNII: 35SW5USQ3G)
FD&C Blue No. 1(UNII: H3R47K3TBD)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorGREENScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code2;1;2;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2154-030 in 1 BOTTLE
2NDC:54868-2154-1100 in 1 BOTTLE
3NDC:54868-2154-210 in 1 BOTTLE
4NDC:54868-2154-345 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921802/09/200906/30/2012
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-4063(NDC:0056-0188)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium3 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
FD&C Yellow No. 6(UNII: H77VEI93A8)
FD&C Blue No. 2(UNII: L06K8R7DQK)
FD&C Red No. 40(UNII: WZB9127XOA)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorBROWN (Tan)Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code3;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-4063-030 in 1 BOTTLE
2NDC:54868-4063-110 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921811/10/200506/30/2010
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-3399(NDC:0056-0168)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium4 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
FD&C Blue No. 1(UNII: H3R47K3TBD)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code4;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-3399-0100 in 1 BOTTLE
2NDC:54868-3399-130 in 1 BOTTLE
3NDC:54868-3399-210 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921811/21/2000
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-1259(NDC:0056-0172)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium5 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
FD&C Yellow No. 6(UNII: H77VEI93A8)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorORANGE (Peach)Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code5;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-1259-020 in 1 BOTTLE
2NDC:54868-1259-130 in 1 BOTTLE
3NDC:54868-1259-590 in 1 BOTTLE
4NDC:54868-1259-610 in 1 BOTTLE
5NDC:54868-1259-775 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921811/15/2004
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5255(NDC:0056-0189)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium6 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
FD&C Yellow No. 6(UNII: H77VEI93A8)
FD&C Blue No. 1(UNII: H3R47K3TBD)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorTURQUOISE (Teal)Score2 pieces
ShapeROUNDSize9mm
FlavorImprint Code6;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5255-030 in 1 BOTTLE
2NDC:54868-5255-110 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921803/23/2005
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-2252(NDC:0056-0173)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium7.5 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
D&C Yellow No. 10(UNII: 35SW5USQ3G)
FD&C Yellow No. 6(UNII: H77VEI93A8)
aluminum hydroxide(UNII: 5QB0T2IUN0)
Product Characteristics
ColorYELLOWScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code7;1;2;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2252-130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921807/31/1995
COUMADIN
warfarin sodium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-2454(NDC:0056-0174)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
warfarin sodium(UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)warfarin sodium10 mg
Inactive Ingredients
Ingredient NameStrength
lactose(UNII: J2B2A4N98G)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code10;COUMADIN
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2454-130 in 1 BOTTLE
2NDC:54868-2454-210 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA00921806/10/200506/30/2010
Labeler -Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-2129, 54868-2454, 54868-2128, 54868-2154, 54868-4063, 54868-3399, 54868-1259, 54868-5255, 54868-2252) , repack(54868-2129, 54868-2454, 54868-2128, 54868-2154, 54868-4063, 54868-3399, 54868-1259, 54868-5255, 54868-2252)

Revised: 11/2012document Id: 

d975e88b-476c-463b-9600-3fbcdb0e86f2Set id: 91fa852c-b43d-4a55-983b-74aa6827125dVersion: 4Effective Time: 20121115Physicians Total Care, Inc.



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