Warfarin Sodium

WARNING: BLEEDING RISK

BOXED WARNING SECTION

Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ]. Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1) ]. Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions (7) ]. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17) ].

RECENT MAJOR CHANGES

RECENT MAJOR CHANGES SECTION

1. INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Warfarin sodium tablets, are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.

2. DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3. DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Warfarin sodium tablets, USP are supplied as follows: 1 mg Tablets: Light pink, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘1’ on the bottom of other side. 2 mg Tablets: Lavender, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2’ on the bottom of other side. 2.5 mg Tablets: Green, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2 1 / 2 ’ on the bottom of other side. 3 mg Tablets: Tan, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘3’ on the bottom of other side. 4 mg Tablets: Blue, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘4’ on the bottom of other side. 5 mg Tablets: Peach, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘5’ on the bottom of other side. 6 mg Tablets: Teal, Round, Flat Beveled edge tablets de-bossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘6’ on the bottom of other side. 7.5 mg Tablets: Yellow, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘7 1 / 2 ’ on the bottom of other side. 10 mg Tablets: White, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘10’ on the bottom of other side.

4. CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Warfarin Sodium is contraindicated in Pregnancy Warfarin sodium tablets are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1) ]. Warfarin sodium tablets can cause fetal harm when administered to a pregnant woman. Warfarin sodium tablets exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If warfarin sodium tablets are used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1) ]. Warfarin Sodium is contraindicated in patients with: Hemorrhagic tendencies or blood dyscrasias Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see Warnings and Precautions (5.8) ] Bleeding tendencies associated with: − Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract − Central nervous system hemorrhage − Cerebral aneurysms, dissecting aorta − Pericarditis and pericardial effusions − Bacterial endocarditis Threatened abortion, eclampsia, and preeclampsia Unsupervised patients with conditions associated with potential high level of non-compliance Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) [see Adverse Reactions (6) ] Major regional or lumbar block anesthesia Malignant hypertension

5. WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6. ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling: Hemorrhage [see Boxed Warning , Warnings and Precautions (5.1) , and Overdosage (10) ] Tissue Necrosis [see Warnings and Precautions (5.2) ] Calciphylaxis [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Systemic atheroemboli and cholesterol microemboli [see Warnings and Precautions (5.5) ] Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions (5.6) ] Other Clinical Settings with Increased Risks [see Warnings and Precautions (5.8) ] Other adverse reactions to warfarin sodium include: Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) Vascular disorders: vasculitis Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine. Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia Respiratory disorders: tracheal or tracheobronchial calcification General disorders: chills

7. DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8. USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10. OVERDOSAGE

OVERDOSAGE SECTION

11. DESCRIPTION

DESCRIPTION SECTION

Warfarin sodium, USP is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α- acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R - and S -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C 19 H 15 NaO 4 , and its structural formula is represented by the following: Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet, USP intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinized starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each 1 mg tablet contains: D&C Red #30 aluminum lake 2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#2 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue #2 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake 4 mg tablet contains: FD&C Blue#2 5 mg tablet contains: FD&C Yellow # 6 aluminum lake 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #2 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake 10 mg tablet is dye free

12. CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13. NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14. CLINICAL STUDIES

CLINICAL STUDIES SECTION

15. REFERENCES

REFERENCES SECTION

OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16. HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Warfarin sodium tablets, USP are supplied as follows: 1 mg Tablets: Light pink, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘1’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-327-01) and 1000’s count (NDC 76282-327-10) 2 mg Tablets: Lavender, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-328-01) and 1000’s count (NDC 76282-328-10) 2.5 mg Tablets: Green, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2 1 / 2 ’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-329-01) and 1000’s count (NDC 76282-329-10) 3 mg Tablets: Tan, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘3’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-330-01) and 1000’s count (NDC 76282-330-10) 4 mg Tablets: Blue, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘4’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-331-01) and 1000’s count (NDC 76282-331-10) 5 mg Tablets: Peach, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘5’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-332-01) and 1000’s count (NDC 76282-332-10) 6 mg Tablets: Teal, Round, Flat Beveled edge tablets de-bossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘6’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-333-01) and 1000’s count (NDC 76282-333-10) 7.5 mg Tablets: Yellow, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘7 1 / 2 ’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-334-01) 10 mg Tablets: White, Round, Flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘10’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-335-01) Storage: Store at 20° to 25°C (68° F to 77° F). [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Special Handling Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see References (15) ]. Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see Use in Specific Populations (8.1) ] .

17. PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Instructions for Patients Advise patients to: Strictly adhere to the prescribed dosage schedule [see Dosage and Administration (2.1)]. If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses [see Dosage and Administration (2.6)]. Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy [see Dosage and Administration (2.1)]. Be aware that if therapy with warfarin sodium is discontinued, the anticoagulant effects of warfarin sodium may persist for about 2 to 5 days [see Clinical Pharmacology (12.2)]. Avoid any activity or sport that may result in traumatic injury [see Use in Specific Populations (8.4)]. And to tell their physician if they fall often as this may increase their risk for complications. Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables [see Drug Interactions (7.5)]. Contact their physician to report any serious illness, such as severe diarrhea, infection, or fever [see Warnings and Precautions (5) and Adverse Reactions (6)]. Immediately contact their physician when experiencing pain and discoloration of the skin (a purple bruise like rash) mostly on areas of the body with a high fat content, such as breasts, thighs, buttocks, hips and abdomen [see Warnings and Precautions (5.2)]. Immediately contact their physician when experiencing any unusual symptom or pain since Warfarin sodium may cause small cholesterol or athero emboli. On feet it may appear as a sudden cool, painful, purple discoloration of toe(s) or forefoot [see Warnings and Precautions (5.5)]. Immediately contact their physician when taking Warfarin sodium after any heparin formulation therapy and experiencing bloody or black stools or appearance of bruises, or bleeding [see Warnings and Precautions (5.6)]. To tell all of their healthcare professionals and dentists that they are taking Warfarin sodium. This should be done before they have any surgery or dental procedure [see Dosage and Administration (2.7)]. Carry identification stating that they are taking warfarin sodium. Bleeding Risks Advise patients to: Notify their physician immediately if any unusual bleeding or symptoms occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Box Warning and Warnings and Precautions (5.1)]. Concomitant Medications and Botanicals (Herbals) Advise patients to: Not take or discontinue any other drug, including salicylates (e.g., aspirin and topical analgesics), other over-the-counter drugs, and botanical (herbal) products except on advice of your physician [see Drug Interactions (7)]. Pregnancy and Nursing Advise patients to: Notify their physician if they are pregnant or planning to become pregnant or considering breast feeding [see Use in Specific Populations (8.1, 8.2, 8.3)]. Avoid warfarin sodium during pregnancy except in pregnant women with mechanical heart valves, who are at risk of thromboembolism [see Contraindications (4)]. Use effective measures to avoid pregnancy while taking warfarin sodium. This is very important because their unborn baby could be seriously harmed if they take warfarin sodium while they are pregnant [see Use in Specific Populations (8.1, 8.3)]. Revised: 06/2020

MEDICATION GUIDE

SPL MEDGUIDE SECTION

Warfarin Sodium Tablets, USP (war' far in soe' dee um) What is the most important information I should know about warfarin sodium? Warfarin sodium can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium 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 warfarin sodium 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 warfarin sodium tablets. 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 warfarin sodium and affect the dose you need or increase warfarin sodium 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 warfarin sodium tablets. Get your regular blood test to check for your response to warfarin sodium. This blood test is called an INR test. The INR test checks to see how fast your blood clots. Your healthcare provider will decide what INR numbers are best for you. Your dose of warfarin sodium will be adjusted to keep your INR in a target range for you. Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems: pain, swelling, or discomfort headaches, dizziness, or weakness unusual bruising (bruises that develop without known cause or grow in size) nosebleeds bleeding gums bleeding from cuts takes a long time to stop menstrual bleeding or vaginal bleeding that is heavier than normal pink or brown urine red or black stools coughing up blood vomiting blood or material that looks like coffee grounds Some foods and beverages can interact with warfarin sodium and affect your treatment and dose. Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of warfarin sodium. Always tell all of your healthcare providers that you take warfarin sodium. Wear or carry information that you take warfarin sodium. See “What are the possible side effects of warfarin sodium?” for more information about side effects. What is warfarin sodium? Warfarin sodium 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. Who should not take warfarin sodium? Do not take warfarin sodium if: your risk of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if warfarin sodium is right for you. you are pregnant unless you have a mechanical heart valve. Warfarin sodium may cause birth defects, miscarriage, or death of your unborn baby. you are allergic to warfarin or any of the other ingredients in warfarin sodium tablets. See the end of this leaflet for a complete list of ingredients in warfarin sodium tablets. Before taking Warfarin sodium, tell your healthcare provider about all of your medical conditions, including if you: have bleeding problems fall often have liver problems have kidney problems or are undergoing dialysis have high blood pressure have a heart problem called congestive heart failure have diabetes plan to have any surgery or a dental procedure are pregnant or plan to become pregnant. See “ Who should not take warfarin sodium? ” Your health care provider will do a pregnancy test before you start treatment with warfarin sodium. Females who can become pregnant should use effective birth control during treatment, and for at least 1 month after the last dose of warfarin sodium. are breastfeeding. You and your health care provider should decide if you will take warfarin sodium and breastfeed. Check your baby for bruising or bleeding if you take warfarin sodium and breastfeed. Tell all of your healthcare providers and dentists that you are taking warfarin sodium. They should talk to the healthcare provider who prescribed warfarin sodium for you before you have any surgery or dental procedure. Your warfarin sodium 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 warfarin sodium works. Certain medicines may increase your risk of bleeding. See “ What is the most important information I should know about warfarin sodium? ” How should I take warfarin sodium? Take warfarin sodium exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to warfarin sodium. You must have regular blood tests and visits with your healthcare provider to monitor your condition. If you miss a dose of warfarin sodium, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of warfarin sodium the next day to make up for a missed dose. Call your healthcare provider right away if you: take too much warfarin sodium 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 warfarin sodium? Do not do any activity or sport that may cause a serious injury. What are the possible side effects of warfarin sodium? Warfarin sodium may cause serious side effects, including: See “ What is the most important information I should know about warfarin sodium? ” Death of skin tissue (skin necrosis or gangrene). This can happen soon after starting warfarin sodium. 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 Warfarin sodium. Tell your healthcare provider right away if you develop blood in your urine. Your healthcare provider may do tests more often during treatment with Warfarin sodium 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 warfarin sodium. 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 warfarin sodium? Store warfarin sodium tablets at 20°C to 25°C (68°F to 77°F). Keep warfarin sodium tablets in a tightly closed container. Keep warfarin sodium tablets out of the light and moisture. Follow your healthcare provider or pharmacist instructions about the right way to throw away outdated or unused warfarin sodium tablets. Females who are pregnant should not handle crushed or broken warfarin sodium tablets. Keep warfarin sodium tab...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL NDC 76282-327-01 Warfarin Sodium Tablets, USP Crystalline * 1 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-328-01 Warfarin Sodium Tablets, USP Crystalline * 2 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-329-01 Warfarin Sodium Tablets, USP Crystalline * 2.5 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-330-01 Warfarin Sodium Tablets, USP Crystalline * 3 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-331-01 Warfarin Sodium Tablets, USP Crystalline * 4 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-332-01 Warfarin Sodium Tablets, USP Crystalline * 5 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-333-01 Warfarin Sodium Tablets, USP Crystalline * 6 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-334-01 Warfarin Sodium Tablets, USP Crystalline * 7.5 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC. PRINCIPAL DISPLAY PANEL NDC 76282-335-01 Warfarin Sodium Tablets, USP Crystalline * 10 mg PHARMACIST: Dispense the Medication Guide provided separately to each patient. Rx Only 100 Tablets EXELAN PHARMACEUTICALS, INC.