;
This Patient Information leaflet summarizes the most important information about Noxafil. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Noxafil that is written for health care professionals.
For more information, go to www.noxafil.com or call 1-800-672-6372.
What are the ingredients in Noxafil?
Active ingredient: posaconazole
• Noxafil Delayed-Release Tablets:
Inactive ingredients: hypromellose acetate succinate, microcrystalline cellulose, hydroxypropylcellulose, silicon dioxide, croscarmellose sodium, magnesium stearate, and Opadry® II Yellow (consists of the following ingredients: polyvinyl alcohol partially hydrolyzed, Macrogol/PEG 3350, titanium dioxide, talc, and iron oxide yellow)
• Noxafil Oral Suspension:
Inactive ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate, citric acid monohydrate, glycerin, xanthan gum, liquid glucose, titanium dioxide, artificial cherry flavor, and purified water
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Delayed-Release Tablets: Manuf. by: N. V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands
Oral Suspension: Manuf. by: Patheon Inc., Whitby, Ontario, Canada L1N 5Z5
For patent information: www.merck.com/product/patent/home.html
The trademarks depicted in this piece are owned by their respective companies.
Copyright © 2006, 2010, 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 11/2013
usppi-mk5592-mtl-1311r012
PRINCIPAL DISPLAY PANEL - 105 mL Bottle Label
NDC 0085-1328-01
NOXAFIL®
(posaconazole)
Oral Suspension
200 mg/5 mL
Each mL contains: 40 mg posaconazole.
SHAKE WELL BEFORE EACH USE.
Rx only
105 mL
28343337
Principal Display Panel - 105 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
NDC 0085-4324-02
Noxafil®
(posaconazole)
delayed-release tablets
100 mg
Each tablet contains 100 mg posaconazole.
Rx only
60 Tablets
Principal Display Panel - 100 mg Bottle Label
NOXAFIL
posaconazole suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-1328
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
posaconazole (posaconazole) posaconazole 40 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
polysorbate 80
sodium benzoate
trisodium citrate dihydrate
citric acid monohydrate
glycerin
xanthan gum&nbs |
