Generic Name
Dipyridamole
Brand Names
Asprin, Aspirin-Dipyridamole
FDA approval date: October 18, 1996
Classification: Platelet Aggregation Inhibitor
Form: Injection, Tablet, Capsule
What is Asprin (Dipyridamole)?
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. Aspirin and extended-release dipyridamole capsules are a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis
Approved To Treat
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Brand Information
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE (ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE)
1INDICATIONS AND USAGE
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
2DOSAGE AND ADMINISTRATION
Aspirin and extended-release dipyridamole capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets.
The recommended dose of aspirin and extended-release dipyridamole capsules is one capsule given orally twice daily, one in the morning and one in the evening. Swallow capsules whole without chewing. Aspirin and extended-release dipyridamole capsules can be administered with or without food.
2.1Alternative Regimen in Case of Intolerable Headaches
In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.
3DOSAGE FORMS AND STRENGTHS
Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg are available as size ‘0el’ empty hard gelatin capsules with a reddish brown opaque cap and a cream opaque body, imprinted with the Glenmark logo ‘G’ on the cap and ‘405’ on the body with black ink. The capsules are filled with light yellow to yellow colored dipyridamole pellets in extended-release form and a white to off-white aspirin tablet in immediate-release form.
4ADVERSE REACTIONS
The following adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity [
- Allergy [
- Risk of Bleeding [
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The efficacy and safety of aspirin and extended-release dipyridamole was established in the European Stroke Prevention Study-2 (ESPS2). ESPS2 was a double-blind, placebo-controlled study that evaluated 6602 patients over the age of 18 years who had a previous ischemic stroke or transient ischemic attack within ninety days prior to entry. Patients were randomized to either aspirin and extended-release dipyridamole, aspirin, ER-DP, or placebo [
This 24-month, multicenter, double-blind, randomized study (ESPS2) was conducted to compare the efficacy and safety of aspirin and extended-release dipyridamole with placebo, extended-release dipyridamole alone and aspirin alone. The study was conducted in a total of 6602 male and female patients who had experienced a previous ischemic stroke or transient ischemia of the brain within three months prior to randomization.
Table 1 presents the annualized event rate for adverse events that occurred in 1%/year or more of patients treated with Aspirin and extended-release dipyridamole capsules where the incidence was also at least 1%/year greater than in those patients treated with placebo. There is no clear benefit of the dipyridamole/aspirin combination over aspirin with respect to safety.
a Reported by ≥1%/year of patients during Aspirin and extended-release dipyridamole capsules treatment where the incidence was at least 1%/year greater than in those treated with placebo.
b Annual event rate per 100 pt-years = 100* number of subjects with event/subject-years. Subject-years is defined as cumulative number of days on treatment divided by 365.25.
Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for all treatment groups is BID.
NOS = not otherwise specified.
Discontinuation due to adverse events in ESPS2 was 25% for aspirin and extended-release dipyridamole 25% for extended-release dipyridamole 19% for aspirin, and 21% for placebo (refer to Table 2).
Table 2 Incidence of Adverse Events that Led to the Discontinuation of Treatment
a Reported by ≥1%/year of patients during Aspirin and Extended-Release Dipyridamole capsules treatment where the incidence was at least 1%/year greater than in those treated with placebo.
b Annual event rate per 100 pt-years = 100* number of subjects with event/subject-years. Subject-years is defined as cumulative number of days on treatment divided by 365.25.
Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for all treatment groups is BID.
Headache was most notable in the first month of treatment.
4.2Post-Marketing Experience
The following is a list of additional adverse reactions that have been reported either in the literature or are from post-marketing spontaneous reports for either dipyridamole or aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Aspirin and extended-release dipyridamole capsules.
Body as a Whole: Hypothermia, chest pain, allergic reaction, syncope
Cardiovascular: Angina pectoris, hypotension
Central Nervous System: Cerebral edema, dizziness, cerebral hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage
Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis, hypokalemia
Gastrointestinal: Pancreatitis, Reye syndrome, hematemesis, gastritis, ulceration and perforation, hemorrhage rectum, melena, GI hemorrhage
Hearing and Vestibular Disorders: Hearing loss
Heart Rate and Rhythm Disorders: Tachycardia, palpitation
Immune System Disorders: Hypersensitivity, acute anaphylaxis, laryngeal edema
Liver and Biliary System Disorders: Hepatitis, hepatic failure, cholelithiasis, jaundice, hepatic function abnormal
Musculoskeletal: Rhabdomyolysis, myalgia
Metabolic and Nutritional Disorders: Hypoglycemia, dehydration
Platelet, Bleeding and Clotting Disorders: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia, hematoma, gingival bleeding, epistaxis, purpura
Psychiatric Disorders: Confusion, agitation
Respiratory: Tachypnea, dyspnea, hemoptysis
Skin and Appendages Disorders: Rash, alopecia, angioedema, Stevens-Johnson syndrome, skin hemorrhages such as bruising, ecchymosis, and hematoma, pruritus, urticaria, and drug reaction with eosinophilia and systemic symptoms (DRESS)
Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, hematuria
Vascular (Extracardiac) Disorders: Allergic vasculitis, flushing
Other Adverse Events: Anorexia, aplastic anemia, migraine, pancytopenia, thrombocytosis.
5OVERDOSAGE
Because of the dose ratio of dipyridamole to aspirin, overdosage of aspirin and extended-release dipyridamole capsules are likely to be dominated by signs and symptoms of dipyridamole overdose. In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately. Careful medical management is essential.
Based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness, and dizziness may occur. A drop in blood pressure and tachycardia might also be observed.
Salicylate toxicity may result from acute ingestion (overdose) or chronic intoxication. Severity of aspirin intoxication is determined by measuring the blood salicylate level. The early signs of salicylic overdose (salicylism), including tinnitus (ringing in the ears), occur at plasma concentrations approaching 200 mcg/mL. In severe cases, hyperthermia and hypovolemia are the major immediate threats to life. Plasma concentrations of aspirin above 300 mcg/mL are clearly toxic. Severe toxic effects are associated with levels above 400 mcg/mL. A single lethal dose of aspirin in adults is not known with certainty but death may be expected at 30 g.
Treatment of overdose consists primarily of supporting vital functions, increasing drug elimination, and correcting acid-base disturbances. Consider gastric emptying and/or lavage as soon as possible after ingestion, even if the patient has vomited spontaneously. After lavage and/or emesis, administration of activated charcoal as a slurry may be beneficial if less than 3 hours have passed since ingestion. Charcoal absorption should not be employed prior to emesis and lavage. Follow acid-base status closely with serial blood gas and serum pH measurements. Maintain fluid and electrolyte balance. Administer replacement fluid intravenously and augment with correction of acidosis. Treatment may require the use of a vasopressor. Infusion of glucose may be required to control hypoglycemia.
Administration of xanthine derivatives (e.g., aminophylline) may reverse the vasodilatory effects of dipyridamole overdose. Plasma electrolytes and pH should be monitored serially to promote alkaline diuresis of salicylate if renal function is normal. In patients with renal insufficiency or in cases of life-threatening intoxication, dialysis is usually required to treat salicylic overdose; however, since dipyridamole is highly protein bound, dialysis is not likely to remove dipyridamole. Exchange transfusion may be indicated in infants and young children.
6DESCRIPTION
Aspirin and Extended-Release Dipyridamole Capsules are a combination of aspirin and dipyridamole, antiplatelet agents, intended for oral administration. Each hard gelatin capsule contains 200 mg dipyridamole, USP in an extended-release form and 25 mg aspirin, USP as an immediate-release sugar-coated tablet. In addition, each capsule contains the following inactive ingredients: acacia milled powder, eudragit S-100, glyceryl behenate, hydroxy propyl methyl cellulose phthalate HP-55, hypromellose, hypromellose E3LV, hypromellose E50LV, lactose monohydrate, microcrystalline cellulose, micronized talc, povidone K 30, silicon dioxide, talc, tartatic acid pellets and triacetin.
Each capsule shell contains FD & C blue 1, FD & C red 3, FD & C red 40, FD & C yellow 6, gelatin, iron oxide yellow, sodium lauryl sulphate and titanium dioxide.
The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.
Dipyridamole
Dipyridamole is an antiplatelet agent chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4-
- Molecular formula: C
Dipyridamole is an odorless yellow crystalline substance, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and is practically insoluble in water.
Aspirin
The antiplatelet agent aspirin (acetylsalicylic acid) is chemically known as benzoic acid, 2- (acetyloxy)-, and has the following structural formula:
- Molecular formula: C
Aspirin has white crystals, commonly tubular or needle-like, or white, crystalline powder. When exposed to moisture, aspirin hydrolyzes into salicylic and acetic acids, and gives off a vinegary odor. It is slightly soluble in water; freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether.
7CLINICAL STUDIES
ESPS2 (European Stroke Prevention Study-2) was a double-blind, placebo-controlled, 24-month study in which 6602 patients over the age of 18 years had an ischemic stroke (76%) or transient ischemic attack (TIA, 24%) within three months prior to entry. Patients were enrolled in 13 European countries between February 1989 and May 1995 and were randomized to one of four treatment groups: Aspirin and extended-release dipyridamole 25 mg/200 mg; extended-release dipyridamole (ER-DP) 200 mg alone; aspirin (ASA) 25 mg alone; or placebo. The mean age in this population was 66.7 years with 58% of them being males. Patients received one capsule twice daily (morning and evening). Efficacy assessments included analyses of stroke (fatal or nonfatal) and death (from all causes) as confirmed by a blinded morbidity and mortality assessment group. There were no differences with regard to efficacy based on age or gender; patients who were older had a trend towards more events.
Stroke Endpoint
Aspirin and extended-release dipyridamole reduced the risk of stroke by 22.1% compared to aspirin 50 mg/day alone (p = 0.008) and reduced the risk of stroke by 24.4% compared to extended-release dipyridamole 400 mg/day alone (p = 0.002) (Table 3). Aspirin and extended-release dipyridamole reduced the risk of stroke by 36.8% compared to placebo (p <0.001).
- Figure 1 ESPS2: Cumulative Stroke Rate (Fatal or Nonfatal)
Over 24 months of Follow-Up
Combined Stroke or Death Endpoint
In ESPS2, Aspirin and extended-release dipyridamole capsules reduced the risk of stroke or death by 24.2% compared to placebo.
Aspirin and extended-release dipyridamole capsules reduced the risk of stroke or death by 12.1% compared to aspirin alone and by 10.3% compared to extended-release dipyridamole alone. These results were not statistically significant.
Death Endpoint
The incidence rate of all-cause mortality was 11.3% for Aspirin and extended-release dipyridamole capsules, 11% for aspirin alone, 11.4% for extended-release dipyridamole alone and 12.3% for placebo alone. The differences between the Aspirin and extended-release dipyridamole capsules, aspirin alone and extended-release dipyridamole alone treatment groups were not statistically significant. These incidence rates for Aspirin and extended-release dipyridamole capsules and aspirin alone are consistent with previous aspirin studies in stroke and TIA patients.
8HOW SUPPLIED/STORAGE AND HANDLING
Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg are available as size ‘0el’ empty hard gelatin capsules with a reddish brown opaque cap and a cream opaque body, imprinted with the Glenmark logo ‘G’ on the cap and ‘405’ on the body with black ink. The capsules are filled with light yellow to yellow colored dipyridamole pellets in extended-release form and a white to off-white aspirin tablet in immediate-release form.
Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg are supplied in unit-of-use bottles of 30 capsules (NDC 68462-405-30) and unit-of-use bottles of 60 capsules (NDC 68462-405-60).
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Risk of Bleeding
Inform patients that as with other antiplatelet agents, there is a general risk of bleeding including intracranial and gastrointestinal bleeding. Inform patients about the signs and symptoms of bleeding, including occult bleeding. Tell patients to notify their physician if they are prescribed any drug which may increase risk of bleeding.
Counsel patients who consume three or more alcoholic drinks daily about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.
• Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Aspirin and extended-release dipyridamole capsules [see
• Headaches
Some patients may experience headaches upon treatment initiation; these are usually transient. In case of intolerable headaches, tell patients to contact their physician.
- Stress Test
Instruct patients who are scheduled to undergo a pharmacologic stress test to tell their healthcare provider that they are taking aspirin and extended-release dipyridamole capsules.
• Dosage and Administration
Tell patients that aspirin and extended-release dipyridamole capsules should be swallowed whole, and not chewed or crushed. If you miss a dose, continue with your next dose on your regular schedule. Do not take a double dose.
• Storage
Inform patients to protect aspirin and extended-release dipyridamole capsules from moisture.
Manufactured by:
Glenmark Pharmaceuticals Limited
Pithampur, Madhya Pradesh 454775, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
May 2021
10Patient Information
Aspirin (AS-pir-in) and Extended-Release Dipyridamole (dye-pir-ID-a-mole) Capsules
Read this Patient Information before you start taking aspirin and extended-release dipyridamole capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What are Aspirin and Extended-Release Dipyridamole Capsules?
Aspirin and extended-release dipyridamole capsules are a prescription medicine that contains aspirin and a medicine that is slowly released in your body, called dipyridamole. Aspirin and extended-release dipyridamole capsules are used to lower the risk of stroke in people who have had a "mini-stroke" (transient ischemic attack or TIA) or stroke due to a blood clot.
It is not known if aspirin and extended-release dipyridamole capsules are safe and effective in children. See “
Who should not take Aspirin and Extended-Release Dipyridamole Capsules?
Do not take Aspirin and Extended-Release Dipyridamole Capsules if you:
- are allergic to any of the ingredients in aspirin and extended-release dipyridamole capsules. See the end of this leaflet for a list of ingredients in aspirin and extended-release dipyridamole capsules.
- are allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
- have asthma in combination with runny nose and nasal polyps
Do not give aspirin and extended-release dipyridamole capsules to a child or teenager with a viral illness. Reye syndrome, a life-threatening condition, can happen when aspirin (an ingredient in aspirin and extended-release dipyridamole capsules) is used in children and teenagers who have certain viral illnesses.
What should I tell my doctor before using Aspirin and Extended-Release Dipyridamole Capsules?
Before taking Aspirin and Extended-Release Dipyridamole Capsules, tell your healthcare provider if you:
- have stomach ulcers
- have a history of bleeding problems
- have heart problems
- have kidney or liver problems
- have low blood pressure
- have myasthenia gravis
- have any other medical conditions
- are pregnant or plan to become pregnant. You should not take aspirin and extended-release dipyridamole capsules during pregnancy without first talking to your healthcare provider. Tell your healthcare provider right away if you become pregnant while taking aspirin and extended-release dipyridamole capsules.
- are breastfeeding or plan to breastfeed. aspirin and extended-release dipyridamole capsules can pass into your milk. Talk to your healthcare provider about the best way to feed your baby if you take aspirin and extended-release dipyridamole capsules.
Tell your doctor you are taking aspirin and extended-release dipyridamole capsules if you are scheduled to have a stress test for your heart.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. aspirin and extended-release dipyridamole capsules and other medicines may affect each other causing side effects. aspirin and extended-release dipyridamole capsules may affect the way other medicines work, and other medicines may affect how aspirin and extended-release dipyridamole capsules works.
Especially tell your healthcare provider if you take:
- a medicine for high blood pressure, irregular heart beat, or heart failure
- acetazolamide [Diamox
- any blood thinner medicines
- warfarin sodium [Coumadin
- a heparin medicine
- anagrelide [Agrylin
- a seizure medicine
- a medicine for Alzheimer's disease
- a water pill
- methotrexate sodium [Trexall
- aspirin or a non-steroidal anti-inflammatory drug (NSAIDs). You should not take NSAIDs during treatment with aspirin and extended-release dipyridamole capsules. Using these medicines with aspirin and extended-release dipyridamole capsules can increase your risk of bleeding.
- a medicine for diabetes
- probenecid [Probalan
Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.
How should I take Aspirin and Extended-Release Dipyridamole Capsules?
- Take aspirin and extended-release dipyridamole capsules exactly as prescribed. Your healthcare provider will tell you how many aspirin and extended-release dipyridamole capsules to take and when to take them.
- Headaches are not uncommon when you first start taking aspirin and extended-release dipyridamole capsules, but often lessen as treatment continues. Tell your healthcare provider if you have a severe headache. Your healthcare provider may change the instructions for taking aspirin and extended-release dipyridamole capsules.
- Swallow aspirin and extended-release dipyridamole capsules whole. Do not crush or chew the capsules.
- You can take aspirin and extended-release dipyridamole capsules with or without food.
- If you miss a dose, take your next dose at the usual time. Do not take two doses at one time.
- If you take more aspirin and extended-release dipyridamole capsules (overdose) than prescribed, call your healthcare provider or Poison Control Center, or get emergency help right away.
Symptoms of an overdose of Aspirin and Extended-Release Dipyridamole Capsules include:
- a warm feeling or flushing
- sweating
- restlessness
- weakness or dizziness
- a fast heart rate
- ringing in the ears
What should I avoid while using Aspirin and Extended-Release Dipyridamole Capsules?
- heavy alcohol use. People who drink three or more alcoholic drinks every day have a higher risk of bleeding during treatment with aspirin and extended-release dipyridamole capsules, because it contains aspirin.
What are the possible side effects of Aspirin and Extended-Release Dipyridamole Capsules?
Aspirin and extended-release dipyridamole capsules may cause serious side effects, including:
- increased risk of bleeding. You may bleed more easily during aspirin and extended-release dipyridamole capsules treatment, and it may take longer than usual for bleeding to stop. This can include:
- bleeding into your brain (intracranial hemorrhage). This can be a medical emergency. Get medical help right away if you have any of these symptoms while taking aspirin and extended-release dipyridamole capsules:
- severe headache with drowsiness
- confusion or memory change
- pass out (become unconscious)
- bleeding in your stomach or intestine.
- stomach pain
- heartburn or nausea
- vomiting blood or vomit looks like "coffee grounds"
- red or bloody stools
- black stools that look like tar
- bleeding into your brain (intracranial hemorrhage). This can be a medical emergency. Get medical help right away if you have any of these symptoms while taking aspirin and extended-release dipyridamole capsules:
- new or worsening chest pain in some people with heart disease. Tell your healthcare provider if you have new chest pain or have any change in your chest pain during treatment with aspirin and extended-release dipyridamole capsules.
- liver problems, including increased liver function tests and liver failure. Tell your healthcare provider if you have any of these symptoms of a liver problem while taking aspirin and extended-release dipyridamole capsules:
- loss of appetite
- pale colored stool
- stomach area (abdomen) pain
- yellowing of your skin or whites of your eyes
- dark urine
- itching
Call your healthcare provider right away if you have any of the symptoms listed above.
The most common side effects of Aspirin and Extended-Release Dipyridamole Capsules include:
- headache
- upset stomach
- diarrhea
These are not all the possible side effects of aspirin and extended-release dipyridamole capsules. Tell your healthcare provider or pharmacist if you have any side effect that bothers you or that does not go away.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Aspirin and Extended-Release Dipyridamole Capsules?
- Store aspirin and extended-release dipyridamole capsules at room temperature 59ºF to 86ºF (15ºC to 30ºC).
- Keep aspirin and extended-release dipyridamole capsules dry.
Keep aspirin and extended-release dipyridamole capsules and all medicines out of the reach of children.
General information about Aspirin and Extended-Release Dipyridamole Capsules
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information. Do not use aspirin and extended-release dipyridamole capsules for a condition for which it was not prescribed. Do not give aspirin and extended-release dipyridamole capsules to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information summarizes the most important information about aspirin and extended-release dipyridamole capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about aspirin/extended-release dipyridamole capsules that is written for health professionals.
For more information, go to www.glenmarkpharma-us.com or call Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088.
What are the ingredients in Aspirin and Extended-Release Dipyridamole Capsules?
Active Ingredients: dipyridamole in an extended-release form and aspirin
Inactive Ingredients: acacia milled powder, eudragit S-100, glyceryl behenate, hydroxy propyl methyl cellulose phthalate HP-55, hypromellose, hypromellose E3LV, hypromellose E50LV, lactose monohydrate, microcrystalline cellulose, micronized talc, povidone K 30, silicon dioxide, talc, tartatic acid pellets and triacetin.
Each capsule shell contains FD & C blue 1, FD & C red 3, FD & C red 40, FD & C yellow 6, gelatin, iron oxide yellow, sodium lauryl sulphate and titanium dioxide.
The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.
All trademarks are the property of their respective owners.
Manufactured by:
Glenmark Pharmaceuticals Limited
Pithampur, Madhya Pradesh 454775, India
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com
May 2021
11PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Aspirin and Extended-Release Dipyridamole Capsules
25 mg/200 mg – 60 Capsule
NDC 68462-405-60
