e Zuplenz at room temperature, 68°F to 77°F (20°C to 25°C).
•Keep the film in the foil pouch until ready to use. Keep foil pouches in the carton.
•Use the film strip right away, after you take it from the pouch.
Keep Zuplenz and all medicines out of the reach of children.
General information about Zuplenz
Medicines are sometimes used for purposes other than those listed in Patient Information leaflets. Do not use Zuplenz for a condition for which it was not prescribed. Do not give Zuplenz to other people, even if they have the same condition that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Zuplenz. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zuplenz that is written for healthcare professionals. You can also visit www.Zuplenz.com or call 1-800-828-9393.
What are the ingredients in Zuplenz ?
Active ingredient: ondansetron
Inactive ingredients: butylated hydroxytoluene, calcium carbonate, colloidal silicon dioxide, erythritol, hydroxypropyl methylcellulose, monoammonium glycyrrhizinate, peppermint flavor, polyethylene oxide, sodium bicarbonate, sucralose, titanium oxide and xanthan gum.
Manufactured By:
Monosol Rx, LLC
Portage, IN 46368
Distributed By:
Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.
Issued: July 2010
©2010 Par Pharmaceutical, Inc.
Instructions for use
Zuplenz (ZOO-plenz)
(ondansetron)
Oral Soluble Film
1. Keep the film in the foil pouch until ready to use. Use the film right away, after you take it from the pouch.
2. Make sure your hands are dry.
3. Fold the pouch along the dotted line to expose the tear notch. See Figure A.
4. While still folded, tear the pouch carefully along the edge. See Figure B.
5. Take the Zuplenz film strip from the pouch. See Figure C.
6. Put the Zuplenz film on top of your tongue, where it will dissolve in 4 to 20 seconds. See Figure D.
7. Do not chew or swallow the film whole.
8. Swallow after the film dissolves. You may swallow the dissolved film with or without liquid.
9. Wash your hands after taking Zuplenz.
Manufactured By:
Monosol Rx, LLC
Portage, IN 46368
Distributed By:
Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc.
Woodcliff Lake, NJ 07677
Issued July 2010
©2010 Par Pharmaceutical, Inc.
DISPLAY PANEL – CARTON OF 30 X 8MG POUCH
DISPLAY PANEL – CARTON OF 30 X 4 MG POUCH
Zuplenz
ondansetron film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49884-325
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONDANSETRON (ONDANSETRON) ONDANSETRON 8 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
SUCRALOSE
COLLOIDAL SILICON DIOXIDE
TITANIUM DIOXIDE
SODIUM BICARBONATE
XANTHAN GUM
BUTYLATED HYDROXYTOLUENE
Product Characteristics
Color BLACK Score
Shape RECTANGLE Size 32mm
Flavor PEPPERMINT Imprint Code 8;mg
Contains
Pac |
