Fluvoxamine Maleate (Page 11 of 11)

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS at 1-800-308-6755 or FDA at 1-800-FDA-1088.

How should I store Fluvoxamine Maleate Tablets?

Store Fluvoxamine Maleate Tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep Fluvoxamine Maleate Tablets away from high humidity.
Keep FLUVOXAMINE MALEATE TABLETS bottle closed tightly.

Keep Fluvoxamine Maleate Tablets and all medicines out of the reach of children.

General information about Fluvoxamine Maleate Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Fluvoxamine Maleate Tablets for a condition for which it was not prescribed. Do not give Fluvoxamine Maleate Tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Fluvoxamine Maleate Tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Fluvoxamine Maleate Tablets that is written for healthcare professionals.

For more information about Fluvoxamine Maleate Tablets call toll free at 1-800-308-6755 or go to www.anipharmaceuticals.com

What are the ingredients in Fluvoxamine Maleate Tablets?

Active ingredient: Fluvoxamine maleate

Inactive ingredients:

The 25mg tablets: carnauba wax, hypromellose, mannitol, polyethylene glycol, polysorbate 80, pregelatinized starch (potato), silicon dioxide, sodium stearyl fumarate, starch (corn), and titanium dioxide.

The 50mg and 100mg tablets: In addition to the above inactive ingredients, contain synthetic iron oxides.

Manufactured by:

ANI Pharmaceuticals, Inc.

Baudette, MN 56623

9212 Rev 01/17

This Medication Guide has been approved by the U.S. Food and Drug Administration.

FLUVOXAMINE MALEATE TABLET, COATED

Label ImageLabel Image
FLUVOXAMINE MALEATE
fluvoxamine maleate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0637(NDC:62559-159)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE (FLUVOXAMINE) FLUVOXAMINE MALEATE 50 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CARNAUBA WAX
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
STARCH, POTATO
SILICON DIOXIDE
STARCH, CORN
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (3 MPA.S)
POLYETHYLENE GLYCOL 8000
HYPROMELLOSE 2910 (6 MPA.S)
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code 1225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-0637-1 1 TABLET, COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021519 08/09/2011
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-0637)

Revised: 12/2017 Carilion Materials Management

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.