Animi-3 with Vitamin D

Generic Name: folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and soy sterol
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:66213-542-60 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
Revised: 05/2011
 
PBM Pharmaceuticals, Inc
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