ommon cold, sinus infections)
headache
diarrhea
nasal congestion, sore throat, and runny nose (nasopharyngitis)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of XELJANZ/XELJANZ XR. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Pfizer at 1-800-438-1985.
How should I store XELJANZ/XELJANZ XR?
Store XELJANZ/XELJANZ XR at room temperature between 68°F to 77°F (20°C to 25°C).
Safely throw away medicine that is out of date or no longer needed.
Keep XELJANZ/XELJANZ XR and all medicines out of the reach of children.
General information about the safe and effective use of XELJANZ/XELJANZ XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XELJANZ/XELJANZ XR for a condition for which it was not prescribed. Do not give XELJANZ/XELJANZ XR to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about XELJANZ/XELJANZ XR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about XELJANZ/XELJANZ XR that is written for health professionals.
What are the ingredients in XELJANZ?
Active ingredient: tofacitinib citrate
Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6cP, titanium dioxide, macrogol/PEG3350, and triacetin.
What are the ingredients in XELJANZ XR?
Active ingredient: tofacitinib citrate
Inactive ingredients: sorbitol, hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose, HPMC 2910/Hypromellose, titanium dioxide, triacetin, and red iron oxide. Printing ink contains shellac glaze, ammonium hydroxide, propylene glycol, and ferrosoferric oxide/black iron.
LAB-0535-6.0
PRINCIPAL DISPLAY PANEL - 5 MG TABLET BOTTLE LABEL
ALWAYS DISPENSE WITH
MEDICATION GUIDE
NDC 0069-1001-01
Pfizer
Xeljanz®
(tofacitinib) tablets
5 mg*
60 Tablets
Rx only
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label
CLOSE
PRINCIPAL DISPLAY PANEL - 11 MG TABLET BOTTLE LABEL
ALWAYS DISPENSE WITH
MEDICATION GUIDE
Pfizer
NDC 0069-0501-30
Xeljanz® XR
(tofacitinib) tablets
Extended Release Tablets
11 mg*
30 Tablets
Rx only
PRINCIPAL DISPLAY PANEL - 11 mg Tablet Bottle Label
CLOSE
INGREDIENTS AND APPEARANCE
XELJANZ
tofacitinib tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-1001
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
TOFACITINIB CITRATE (UNII: O1FF4DIV0D) (TOFACITINIB - UNII:87LA6FU830) TOFACITINIB 5 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3 |
