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.

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

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