SAPHRIS (Page 11 of 11)

17.9 Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.13)].

17.10 Concomitant Medication and Alcohol

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications since there is a potential for interactions. Patients should be advised to avoid alcohol while taking SAPHRIS [see Drug Interactions (7)].

17.11 Pregnancy and Nursing

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with SAPHRIS. Patients should be advised not to breast feed if they are taking SAPHRIS [see Use in Special Populations (8.1, 8.3)].

Manufactured by: Catalent UK Swindon Zydis Ltd., Blagrove, Swindon, Wiltshire, SN5 8RU, UK

Distributed by: Schering Corporation, a subsidiary of MERCK & CO., INC. , Whitehouse Station, NJ 08889, USA

U.S. Patent No. 5,763,476.

Copyright © 2009 N.V. Organon, a subsidiary of Merck & Co., Inc. All rights reserved.

xxxxx x/xx xx

SAPHRIS PACKAGE LABEL — 10mg/60 tablet carton

Rx only

Label Image
(click image for full-size original)

SAPHRIS asenapine maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-936(NDC:0052-0119)
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASENAPINE MALEATE (ASENAPINE) ASENAPINE MALEATE 10 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MANNITOL
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-936-60 6 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 10 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (16590-936-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022117 08/14/2009
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 02/2011 STAT RX USA LLC

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