Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg

Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg is an FDA-registered drug product whose active ingredient is ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE. It is labelled by Major Pharmaceuticals taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0904-7056, application ANDA207944, label effective 20260819. It is one of 2 FDA drug label records sharing the active ingredient ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE are most often described in connection with: extended-release dipyridamole, indicated reduce, risk stroke, transient ischemia, brain completed, due thrombosis, usage aspirin, capsule combination. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Aspirin and Extended-Release Dipyridamole Capsule is 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 Capsule is 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 ( 1 )

2 DOSAGE 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. • One capsule twice daily (morning and evening) with or without food ( 2 ) • In case of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning; resume BID dosing within one week ( 2.1 ) • Do not chew capsule ( 2 ) • Not interchangeable with the individual components of aspirin and dipyridamole tablets ( 2 ) • Dispense in this unit-of-use container ( 16 ) 2.1 Alternative 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.

4 CONTRAINDICATIONS • Hypersensitivity to any product ingredients ( 4.1 ) • Patients with known allergy to NSAIDs ( 4.2 ) • Patients with the syndrome of asthma, rhinitis, and nasal polyps ( 4.2 ) 4.1 Hypersensitivity Aspirin and extended-release dipyridamole is contraindicated in patients with known hypersensitivity to any of the product components. 4.2 Allergy Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (NSAID) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema or bronchospasm. 4.3 Reye Syndrome Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome.

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity [see Contraindications ( 4.1 )] • Allergy [see Contraindications ( 4.2 )] • Risk of Bleeding [see Warnings and Precautions ( 5.1 )] • The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 [see Clinical Studies ( 14 )] ; primary endpoints included stroke (fatal or nonfatal) and death from all causes. 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 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. Table 1 Incidence of Adverse Events in ESPS2 a Individual Treatment Group Body System/Preferred Term Aspirin and Extended-Release Dipyridamole n (%/year) b ER-DP Alone n (%/year) b ASA Alone n (%/year) b Placebo n (%/year) b Total Number of Patients 1,650 1,654 1,649 1,649 Central and Peripheral Nervous System Disorders Headache 647 (28.25) 634 (27.91) 558 (22.10) 543 (22.29) Gastrointestinal System Disorders Dyspepsia 303 (13.23) 288 (12.68) 299 (11.84) 275 (11.29) Abdominal Pain 289 (12.62) 255 (11.22) 262 (10.38) 239 (9.81) Nausea 264 (11.53) 254 (11.18) 210 (8.32) 232 (9.53) Diarrhea 210 (9.17) 257 (11.31) 112 (4.44) 161 (6.61) Vomiting 138 (6.03) 129 (5.68) 101 (4.00) 118 (4.84) Platelet, Bleeding and Clotting Disorders Hemorrhage NOS 52 (2.27) 24 (1.06) 46 (1.82) 24 (0.99) a Reported by ≥1%/year of patients during aspirin and extended-release dipyridamole 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 Treatment Groups Aspirin and Extended-Release Dipyridamole n (%/year) b ER-DP n (%/year) b ASA n (%/year) b Placebo n (%/year) b Total Number of Patients 1,650 1,654 1,649 1,649 Patients with at least one Adverse Event that led to treatment discontinuation 417 (18.21) 419 (18.44) 318 (12.59) 352 (14.45) Headache 165 (7.20) 166 (7.31) 57 (2.26) 69 (2.83) Nausea 91 (3.97) 95 (4.18) 51 (2.02) 53 (2.18) Abdominal Pain 74 (3.23) 64 (2.82) 56 (2.22) 52 (2.13) Vomiting 53 (2.31) 52 (2.29) 28 (1.11) 24 (0.99) a Reported by ≥1%/year of patients during aspirin and extended-release dipyridamole 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. 6.2 Post 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. 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.

FDA lists 2 drug label records with ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg used for?
1 INDICATIONS AND USAGE Aspirin and Extended-Release Dipyridamole Capsule is 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 Capsule is a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who …

Who makes Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg?
Major Pharmaceuticals is the labeler of record for Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg. 2 FDA label records share the active ingredient ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE?
Yes. 2 FDA drug label records list ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.