Optimal long-term maintenance dosage should be determined at 6-12 month intervals (see PRECAUTIONS, Laboratory Tests).
It is important that SYPRINE be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.
HOW SUPPLIED
Capsules SYPRINE, 250 mg, are light brown opaque capsules coded SYPRINE on one side and ATON 710 on the other. They are supplied as follows:
NDC 25010-710-15 in bottles of 100.
Storage
Keep container tightly closed.
Store at 2-8°C (36-46°F).
Distributed by:
ATON PHARMA
Lawrenceville
NJ 08648
USA
Manufactured by:
Draxis Specialty Pharmaceuticals, Inc.
Kirkland, Quebec H9H 4J4
Issued June 2008
201280
PRINCIPAL DISPLAY PANEL - 250 mg Capsule Carton
ATON
PHARMA
NDC 25010-710-15
100 Capsules
SYPRINE®
(TRIENTINE
HYDROCHLORIDE)
250 mg
Rx only
Distributed by:
ATON PHARMA, INC.
Lawrenceville, NJ 08648, USA
SYPRINE
trientine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25010-710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
trientine hydrochloride(trientine) trientine hydrochloride 250mg
Inactive Ingredients
Ingredient Name Strength
Gelatin
Stearic Acid
Titanium Dioxide
Product Characteristics
Color BROWN (light brown) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code Aton;710;Syprine
Contains
Packaging
NDC Package Description Multilevel Packaging
1 25010-710-15 1BOTTLEIn1CARTON contains a BOTTLE
1 100CAPSULEIn1BOTTLE This package is contained within the CARTON(25010-710-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019194 11/08/1985
Labeler -Aton Pharma, Inc.(795419675)
Establishment
Name Address ID/FEI Operations
Draxis Pharma, Inc. (Produits Pharmaceutiques Specialises Draxis Inc) 243604761 MANUFACTURE
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