Animi-3

Name: Animi-3

Description

Animi-3® 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® 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.

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.

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. 0113
©2013 All Rights Reserved.

NDC 66213-543-60 60 Capsules

Animi-3®

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 
folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent, phytosterols capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66213-543
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;3
Contains     
Packaging
# Item Code Package Description
1 NDC:66213-543-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
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(66213-543)
Revised: 02/2013   PBM Pharmaceuticals, Inc
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