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).

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Keep Fluvoxamine Maleate Tablets away from high humidity.

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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 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