Animi-3 with Vitamin D
Animi-3 with Vitamin D
d77846ab-bce6-4646-8c09-ddfcf09898a3
HUMAN PRESCRIPTION DRUG LABEL
May 23, 2011
PBM Pharmaceuticals, Inc
DUNS: 785470050
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Folic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Cyanocobalamin, Omega-3 Fatty Acids, Doconexent, Icosapent
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (18)
Drug Labeling Information
INDICATIONS & USAGE SECTION
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.
CONTRAINDICATIONS SECTION
This product is contraindicated in patients with a known hyper-sensitivity to any of the ingredients.
WARNINGS AND PRECAUTIONS SECTION
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.
ADVERSE REACTIONS SECTION
Adverse Reactions
Allergic sensitization has been reported following oral, enteral and parenteral administration of folic acid.
SPL PATIENT PACKAGE INSERT SECTION
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
PEDIATRIC USE SECTION
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
DESCRIPTION SECTION
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).
WARNINGS SECTION
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.
PREGNANCY SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Dosage and Administration
Adults – One capsule per day or as directed by a physician.
HOW SUPPLIED SECTION
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).
STORAGE AND HANDLING SECTION
Storage Conditions:
Store at 20-25°C (68-77°F). See USP Controlled Room Temperature. Protect from light and moisture.
SPL UNCLASSIFIED SECTION
PBM Pharmaceuticals, Inc.
Charlottesville, VA 22902
Rev. 0411
©2011 All Rights Reserved.