QUILLIVANT  XR- methylphenidate hydrochloride suspension, extended release 
NextWave Pharmaceuticals, Inc.

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Instructions for Use
QUILLIVANT XR® (\kwil-ə-vant\)
(methylphenidate hydrochloride)
for extended-release oral suspension CII
Read this Instructions for Use before using QUILLIVANT XR and each time you get a refill. There may be new information. This leaflet does not take the place of talking with the health care provider about your or your child's medical condition or treatment.
Step 1. Remove the QUILLIVANT XR bottle and oral dosing dispenser from the box (See Figure A). If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.Step 2. Check and make sure that the QUILLIVANT XR bottle contains liquid medicine (See Figure B). If QUILLIVANT XR is still in powder form, do not use it. Return it to your pharmacist.

Figure A
Figure A

Figure B
Figure B

Step 3. Shake the bottle well (up and down) for at least 10 seconds before each use (See Figure C). Step 4. Uncap the bottle and check that the bottle adapter has been fully inserted into the bottle (See Figure D).

Figure C
Figure C

Figure D
Figure D

Step 4 (continued). If bottle adapter (See Figure E) has not been inserted by the pharmacist into the bottle, insert adapter into the bottle as shown (See Figure F and Figure G).

Figure E
Figure E

Figure F
Figure F

After the bottle adapter has been fully inserted into the bottle (See Figure G), it should not be removed. If the bottle adapter has not been inserted and is missing from the box, contact your pharmacist.
The bottle adapter must be fully inserted and should be even with the mouth of the bottle and must remain in place to allow the child resistant cap to work the right way.

Figure G
Figure G

Step 5. Check the QUILLIVANT XR dose in milliliters (mL) as prescribed by your health care provider. Locate this number on the oral dosing dispenser (See Figure H).Step 6. Insert tip of the oral dosing dispenser into the upright bottle and push the plunger all the way down (See Figure I).

Figure H
Figure H

Figure I
Figure I

Step 7. With the oral dosing dispenser in place, turn the bottle upside down. Pull the plunger to the number of mL you need (the amount of liquid medicine in Step 5 – See Figure J).Step 7 (continued). Measure the number of mL of medicine from the white end of the plunger (See Figure K)

Figure J
Figure J

Figure K
Figure K

Step 8. Remove the oral dosing dispenser from the bottle adapter.
Step 9. Slowly squirt QUILLIVANT XR directly into your or your child's mouth (See Figure L).Step 10. Cap the bottle tightly. Store the bottle upright at 59°F to 86°F (15°C to 30°C) (See Figure M)

Figure L
Figure L

Figure M
Figure M

Step 11. Clean the oral dosing dispenser after each use by placing in the dishwasher, or by rinsing with tap water (See Figure N).

Figure N
Figure N

These Instructions for Use have been approved by the U.S. Food and Drug Administration.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-0658-5.0
June 2017

Revised: 6/2017
Document Id: 39660b40-4652-433e-b5d9-a0fd50eb49f1
Set id: e0157005-6e3e-4763-b910-9eb0937608c9
Version: 21
Effective Time: 20170619
 
NextWave Pharmaceuticals, Inc.