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
SAPHRIS asenapine maleate tablet | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
|
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
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.