Onzetra Xsail (Page 6 of 6)

Instructions for Use

Read these Instructions for Use which come with ONZETRA® Xsail® before you start using it and each time you get a refill. Follow these instructions each time you use ONZETRA Xsail.

Figure
(click image for full-size original)

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

ONZETRA and Xsail are registered trademarks of Currax™ Pharmaceuticals LLC in the United States and other countries. The other brands listed are trademarks of their respective owners and are not trademarks of Currax™ Pharmaceuticals LLC. The makers of these brands are not affiliated with and do not endorse Currax™ Pharmaceuticals LLC or its products.

U.S. Patent Nos, 6,715,485; 7,975,690; 8,047,202; 8,327,844; 8,550,073; 8,555,877; 8,590,530; 8,875,704; 8,899,229; 8,978,647; 9,108,015; 9,119,932

Distributed by:
Currax™ Pharmaceuticals LLC
Morristown, NJ 07960
1-800-793-2145
Issued December 2019

ONZ-LC104.00

© 2019 Currax™ Pharmaceuticals LLC. All rights reserved

PRINCIPAL DISPLAY PANEL — 11 mg Pouch Carton

NDC 42847-311-08

ONZETRA® Xsail®
(sumatriptan nasal powder)
11 mg per nosepiece

Rx Only
For Intranasal Use Only

PLEASE READ INSTRUCTIONS FOR USE.

FOR USE WITH XSAIL®
INTRANASAL DEVICE ONLY

The
Breath Powered®
intranasal medicationdelivery system

PRINCIPAL DISPLAY PANEL -- 11 mg Pouch Carton
(click image for full-size original)
ONZETRA XSAIL sumatriptan succinate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42847-311
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (Sumatriptan) Sumatriptan 11 mg
Product Characteristics
Color WHITE (clear) Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code 825
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42847-311-08 8 POUCH in 1 CARTON contains a POUCH
1 2 CAPSULE in 1 POUCH This package is contained within the CARTON (42847-311-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206099 10/01/2015
Labeler — Currax Pharmaceuticals LLC (117055730)
Establishment
Name Address ID/FEI Operations
PTI Royston LLC 601006997 MANUFACTURE (42847-311)
Establishment
Name Address ID/FEI Operations
UPM Pharmaceuticals, Inc 081301372 MANUFACTURE (42847-311)
Establishment
Name Address ID/FEI Operations
NATCO Pharma Limited, Chemical Division 862497174 API MANUFACTURE (42847-311)
Establishment
Name Address ID/FEI Operations
Patheon, Inc 240769596 ANALYSIS (42847-311)

Revised: 07/2021 Currax Pharmaceuticals LLC

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