Fluvoxamine Maleate (Page 11 of 11)

How should I take Fluvoxamine Maleate Tablets?

  • Take Fluvoxamine Maleate Tablets exactly as prescribed. Your healthcare provider may need to change the dose of Fluvoxamine Maleate Tablets until it is the right dose for you.
  • Fluvoxamine Maleate Tablets may be taken with or without food.
  • If you miss a dose of Fluvoxamine Maleate Tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Fluvoxamine Maleate Tablets at the same time.
  • If you take too much Fluvoxamine Maleate Tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking Fluvoxamine Maleate Tablets?

Fluvoxamine Maleate Tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Fluvoxamine Maleate Tablets affects you. Do not drink alcohol while using Fluvoxamine Maleate Tablets.

What are the possible side effects of Fluvoxamine Maleate Tablets?

Fluvoxamine Maleate Tablets may cause serious side effects, including:

  • See “What is the most important information I should know about Fluvoxamine Maleate Tablets?”
  • Feeling anxious or trouble sleeping

Common possible side effects in people who take Fluvoxamine Maleate Tablets include:

  • nausea
  • sleepiness
  • weakness
  • indigestion
  • sweating
  • loss of appetite
  • shaking
  • vomiting
  • delayed ejaculation
  • inability to have an orgasm
  • decreased sex drive
  • dry mouth
  • stuffy nose
  • unusual taste
  • frequent urination

Other side effects in children and adolescents include:

  • agitation or abnormal increase in activity
  • feeling depressed or sad
  • excessive gas
  • heavy menstrual periods
  • rash
  • possible slowed growth rate and weight change

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 Fluvoxamine Maleate Tablets. For more information, ask your healthcare provider or pharmacist.

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

Repackaged By :
Aidarex Pharmaceuticals LLC,Corona, CA 92880

9212Rev 12/12

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

PRINCIPAL DISPLAY PANEL- Fluvoxamine Maleate Tablets 50 mg

IMAGE LABEL
(click image for full-size original)

NDC 33261-0683-30

Fluvoxamine Maleate Tablets, USP

50 mg

Rx only

30 Tablets

EACH TABLET CONTAINS:

Fluvoxamine Maleate, USP………50 mg

For DOSAGE & ADMINISTRATION and WARNINGS: See package insert and BOXED WARNING.

Dispense in a tight container with child-resistant closure.

Protect from high humidity.

Sore at 25ºC (77ºF); excursions permitted 15º to 30ºC (59º-86ºF) .[see USP Controlled Room Temperature].

[See USP Controlled Room Temperature]

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
9214

Repackaged By :
Aidarex Pharmaceuticals LLC,Corona, CA 92880

Rev 01/13

LOT:

EXP:

FLUVOXAMINE MALEATE fluvoxamine maleate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-683(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:33261-683-30 30 TABLET, COATED (30 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021519 08/09/2011
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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