ASPIRIN-DIPYRIDAMOLE capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)

Tilgjengelig fra:

Zydus Lifesciences Limited

INN (International Name):

ASPIRIN

Sammensetning:

ASPIRIN 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 contraindicated in patients with known hypersensitivity to any of the product components. 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. Do not use aspirin in children or teenagers with viral infections because of the risk of Reye syndrome. Risk Summary Available data from published studies and postmarketing experience with aspirin and extended-release dipyridamole capsule use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsule use and major birth defects, miscarriage, or adverse maternal or fetal

Produkt oppsummering:

Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and opaque white body, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows: NDC 70771-1172-6 in bottle of 60 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Protect from excessive moisture.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ASPIRIN-DIPYRIDAMOLE - ASPIRIN-DIPYRIDAMOLE CAPSULE
ZYDUS LIFESCIENCES LIMITED
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ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1172-6
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg
Rx only
60 Capsules
ASPIRIN-DIPYRIDAMOLE
aspirin-dipyridamole capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1172
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
ASPIRIN
25 mg
DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
DIPYRIDAMOLE
200 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) (UNII:
5KY68S2577)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
RED (OPAQUE RED CAP) , WHITE (OPAQUE WHITE BODY)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
24mm
FLAVOR
IMPRINT CODE
618
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1172-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
01/04/2018
Zydus Lifesciences Limited
MARKETING