Animi-3 with Vitamin D

folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and soy sterol

Dosage Form: capsule
Animi-3 with Vitamin D

Package Insert

Animi-3® with Vitamin D

    Each Capsule Contains:

    Folic Acid (Vitamin B9)                              1mg

    Cholecalciferol (Vitamin D3)                       1000IU

    Pyridoxine Hydrochloride (Vitamin B6)        12.5mg

    Cyanocobalamin (Vitamin B12)                   500mcg

    Omega-3 Acids                                         500mg

    -Docosahexaenoic Acid (DHA)                    350mg

    -Eicosapentaenoic Acid (EPA)                    35mg

    Phytosterols (Plant Sterols)                        200mg

Patent Pending

Rx Only

Description

Animi-3® with Vitamin D Capsules are intended for oral administration.

Each Capsule Contains: 1mg Vitamin B-9 (Folic Acid USP), 1000IU Vitamin D-3 (Cholecalciferol), 12.5mg Vitamin B-6 (Pyridoxine Hydrochloride, USP), 500mcg vitamin B-12 (Cyanocobalamin, USP), Pharmaceutical Grade omega-3 Fish Oil providing 500mg Omega-3 Acids; including 350mg Docosahexaenoic Acid (DHA) and 35mg Eicosapentaenoic Acid (EPA) and 200mg Plant Sterols (Phytosterols).

Also Contains: Bleached Lecithin NF, Ascorbic Acid USP, Mixed Tocopherols NF, Ascorbyl Palmitate NF and a soft shell capsule (which contains; Gelatin USP, Glycerin NF, Titanium Dioxide USP, FD and C Red #40, FD and C Yellow #6 and USP Purified Water).

Indication

Animi-3® with Vitamin D Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.

This product is contraindicated in patients with a known hyper-sensitivity to any of the ingredients.

Warning

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis.

Warning

Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Pregnancy and Lactation

The safety of phytosterols has not been studied in pregnant or breastfeeding women. There is no evidence that dietary intakes of naturally occurring phytosterols, such as those consumed by vegetarian women, adversely affects pregnancy or lactation.

Adverse Reactions

Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.

Dosage and Administration

Adults – One capsule per day or as directed by a physician.

How Supplied

Animi-3® with Vitamin D supplied as orange opaque oblong capsules. Each capsule in imprinted with “Animi-3D” in black opacode. Animi-3® with Vitamin D Capsules are available in bottles of 60 capsules (NDC 66213-542-60).

Keep out of reach of children.

Dispense in a well-closed, tight light-resistant container as defined in the USP using a child-resistant closure.

Storage Conditions:

Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.

PBM Pharmaceuticals, Inc.

Charlottesville, VA 22902

Rev. 0411

©2011 All Rights Reserved.

NDC  66213-542-60     60 Capsules


Animi 3D with Vitamin D


Folic Acid (Vitamin B-9)         1 mg

Cholecalciferol (Vitamin D-3)     1000 IU

Pyridoxine Hydrochloride (Vitamin B-6)     12.5 mg

Cyanocobalamin (Vitamin B-12)     500 mcg

Omega 3 Acids      500 mg

– Docosahexaenoic Acid (DHA)    350 mg

– Eicosapentaenoic Acid (EPA)    35 mg

Phytosterols (Plant Sterols)    200 mg


Rx Only

Animi-3 with Vitamin D  folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66213-542 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (Folic Acid) Folic Acid 1 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 1000 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 12.5 mg Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 500 ug Omega-3 Fatty Acids (Omega-3 Fatty Acids) Omega-3 Fatty Acids 500 mg Doconexent (Doconexent) Doconexent 250 mg Icosapent (Icosapent) Icosapent 35 mg Soy Sterol (Soy Sterol) Soy Sterol 200 mg

Inactive Ingredients Ingredient Name Strength Ascorbic Acid   Alpha-Tocopherol   Ascorbyl Palmitate   Gelatin   Glycerin   Titanium Dioxide   FD&C Red No. 40   Water   Lecithin, Soybean   FD&C Yellow No. 6

Product Characteristics Color orange Score no score Shape OVAL (Capsule) Size 20mm Flavor Imprint Code Animi;3D Contains

Packaging # NDC Package Description Multilevel Packaging 1 66213-542-60 60 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2011

Labeler - PBM Pharmaceuticals, Inc (785470050)

Establishment
Name	Address	ID/FEI	Operations
International Vitamin Corporation		964464114	manufacture

Revised: 05/2011PBM Pharmaceuticals, Inc

More Animi-3 with Vitamin D resources

• Animi-3 with Vitamin D Side Effects (in more detail)
• Animi-3 with Vitamin D Dosage
• Animi-3 with Vitamin D Use in Pregnancy & Breastfeeding
• Animi-3 with Vitamin D Drug Interactions
• 0 Reviews for Animi-3 with Vitamin D - Add your own review/rating

• Animi-3 MedFacts Consumer Leaflet (Wolters Kluwer)


• Divista MedFacts Consumer Leaflet (Wolters Kluwer)


• Fish Oil Consumer Overview


• Lovaza Advanced Consumer (Micromedex) - Includes Dosage Information


• Lovaza MedFacts Consumer Leaflet (Wolters Kluwer)


• Omacor Monograph (AHFS DI)


• Omacor Consumer Overview

Compare Animi-3 with Vitamin D with other medications

• ADHD
• Dietary Supplementation
• Hypertriglyceridemia