Zolmitriptan (Page 7 of 7)

Instructions for Use

Zolmitriptan (zohl-mi-TRIP-tan)

Nasal Spray

Important: For use in your nose only. Do not spray in your eyes.

Note: There is only 1 dose in the nasal sprayer. Do not try to prime the nasal sprayer or you will lose the dose. Do not press the plunger until you have put the tip into your nostril or you will lose the dose.

Steps for using Zolmitriptan Nasal Spray

Step 1. Remove the Zolmitriptan Nasal Spray unit from the box it comes in. Do not remove the unit from the plastic pack until you are ready to use it. The unit contains only 1 spray.

Step 2. Blow your nose gently to clear your nasal passages before use.

Step 3. Peel back the tab to remove the Zolmitriptan Nasal Spray unit from the plastic pack (See Figure A).

Step 4. Keeping your head in an upright position, gently close 1 nostril with your index finger and breathe out gently through your mouth. (See Figure B). Either nostril can be used.

Step 5. With your other hand, hold the container with your thumb supporting the container at the bottom, and your index and middle fingers on each side of the nozzle. (See Figure C).

Insert the tip of the sprayer device into your open nostril as far as feels comfortable and tilt your head slightly (See Figure D).

Do not press the plunger yet.

Step 6. Breathe in gently through your nose and at the same time press the plunger firmly with your thumb to release your dose of Zolmitriptan Nasal Spray (See Figure D).

The plunger may feel stiff and you may hear a click. Keep your head slightly tilted back and remove the tip from your nose. Breathe gently through your mouth for 5 to 10 seconds. You may feel liquid in your nose or the back of your throat. This is normal.

Step 7. Dispose the Zolmitriptan Nasal Spray device after completing the full dose or as soon as it becomes outdated or no longer needed. Dispose of properly. Keep out of reach of children. Do not reuse.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigorx.com

Rev 11-20

6R600 RC J1

Package/Label Display Panel

Rx Only

NDC 45802-711-91

Zolmitriptan Nasal Spray, USP

5 mg

For Intranasal Use Only

This pack contains:

6 single-use nasal spray devices

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

ZOLMITRIPTAN zolmitriptan spray

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-711 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZOLMITRIPTAN (ZOLMITRIPTAN) ZOLMITRIPTAN 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE WATER BENZALKONIUM CHLORIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:45802-711-91 6 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY (45802-711-00) 1 NDC:45802-711-00 1 SPRAY in 1 BOTTLE, SPRAY This package is contained within the CARTON (45802-711-91)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212469 11/16/2021

Labeler — Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021 Padagis Israel Pharmaceuticals Ltd