DURLAZA (Page 3 of 3)

PACKAGE LABEL

NDC 58487-001-02
DURLAZA™
(ASPIRIN)
Extended Release Capsules

162.5 mg
Rx Only
90 Capsules

DOSAGE: See package insert for full Prescribing Information.
Take DURLAZA once daily.
Swallow capsules whole.
Do not cut, crush or chew.
Each capsule contains 162.5 mg of aspirin.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
www.durlaza.com
Manufactured for:
New Haven Pharmaceuticals, Inc.
North Haven, CT 06473
Made in USA
©2015 New Haven Pharmaceuticals, Inc.
19959
LOT:
EXP:

90 count label
(click image for full-size original)

PACKAGE LABEL

NDC 58487-001-01
DURLAZA™
(ASPIRIN)
Extended Release Capsules

162.5 mg
Rx Only
30 Capsules

DOSAGE: See package insert for full Prescribing Information.
Take DURLAZA once daily.
Swallow capsules whole.
Do not cut, crush or chew.
Each capsule contains 162.5 mg of aspirin.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
Manufactured for:
New Haven Pharmaceuticals, Inc.
North Haven, CT 06473
Made in USA
www.durlaza.com
©2015 New Haven Pharmaceuticals, Inc.
19958
LOT:
EXP:

30 count label
(click image for full-size original)
DURLAZA acetylsalicylic acid capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58487-001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 162.5 mg
Inactive Ingredients
Ingredient Name Strength
Ethylcelluloses
Povidones
Castor Oil
Tartaric Acid
Magnesium Stearate
Silicon Dioxide
Talc
Gelatin
Titanium Dioxide
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (OBLONG) Size 18mm
Flavor Imprint Code DURLAZA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58487-001-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:58487-001-02 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200671 09/25/2015
Labeler — New Haven Pharmaceuticals, Inc. (078715268)
Establishment
Name Address ID/FEI Operations
PATHEON PHARMACEUTICALS INC. 005286822 MANUFACTURE (58487-001)

Revised: 09/2015 New Haven Pharmaceuticals, Inc.

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