ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42571-274-60
Aspirin and
Extended-Release
Dipyridamole Capsules
25 mg/200 mg
Unit-of-use Container
Rx only
60 Capsules MICRO LABS LIMITED

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ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE aspirin and extended-release dipyridamole capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-274
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 25 mg
DIPYRIDAMOLE (DIPYRIDAMOLE) DIPYRIDAMOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C BLUE NO. 1
GLYCERYL MONOSTEARATE
HYPROMELLOSE 2910 (6 MPA.S)
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
POVIDONE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TARTARIC ACID
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
GELATIN
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
POLYVINYL ALCOHOL
AMMONIA
Product Characteristics
Color red (red opaque colored cap and ivory opaque colored body) Score no score
Shape CAPSULE (capsule) Size 24mm
Flavor Imprint Code M25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-274-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209929 08/16/2021
Labeler — Micro Labs Limited (862174955)
Establishment
Name Address ID/FEI Operations
Micro Labs Limited 915793658 analysis (42571-274), label (42571-274), manufacture (42571-274), pack (42571-274)

Revised: 11/2021 Micro Labs Limited

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