effects to FDA at 1-800-FDA-1088.
How should I store HORIZANT?
Store HORIZANT between 59° and 86°F (15° and 30°C).
Keep HORIZANT dry and away from moisture.
Keep HORIZANT tightly closed in the bottle provided to you. Do not remove any moisture control packs that may come in the bottle.
Keep HORIZANT and all medicines out of the reach of children.
General Information about the safe and effective use of HORIZANT
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HORIZANT for a condition for which it was not prescribed. Do not give HORIZANT to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about HORIZANT. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about HORIZANT that was written for healthcare professionals.
For more information about HORIZANT, go to www.HORIZANT.com or call 1-877-XENOPRT (1-877-936-6778).
What are the ingredients in HORIZANT?
Active ingredients: gabapentin enacarbil
Inactive ingredients: Both the 300 mg and 600 mg tablets contain colloidal silicon dioxide, dibasic calcium phosphate dihydrate, glyceryl behenate, magnesium stearate, sodium lauryl sulfate, and talc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
XenoPort, Inc.
Santa Clara,CA95051
Revised: July 201
HORIZANT is a registered trademark of XenoPort. The other brands listed are trademarks of their respective owners and are not trademarks of XenoPort. The makers of these brands are not affiliated with and do not endorse XenoPort or its products.
©2013, XenoPort. All rights reserved.
HZT:9MG
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 300 mg, 30 ct Bottle Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 300 mg, 5 ct Bottle Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 600 mg, 30 ct Bottle Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - 600 mg, 5 ct Bottle Label
INGREDIENTS AND APPEARANCE
HORIZANT
gabapentin enacarbil tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53451-0103
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN ENACARBIL (UNII: 75OCL1SPBQ) (GABAPENTIN - UNII:6CW7F3G59X) GABAPENTIN ENACARBIL 300 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) 259.1 mg
TALC (UNII: 7SEV7J4R1U) 40.0 mg
GLYCERYL BEHENATE (UNII: R8WTH25YS2) 30.1 mg
MAGNESIUM STEARATE (UNII: 70097M6I30) 11.1 mg
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 12.0 mg
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2.7 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code GS;TF7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53451-0103-1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:53451-0103-9 5 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monog |
