Label: ANIMI-3- folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent, phytosterols capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 66213-543-60 - Packager: PBM Pharmaceuticals, Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 6, 2013
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Package Insert
Animi-3®
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) 200mgU.S. Patent No. 8,075,910; 8,173,160
Rx Only -
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
- CONTRAINDICATIONS
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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.
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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
- Pregnancy and Lactation
- Adverse Reactions
- Dosage and Administration
- How Supplied
- Keep out of reach of children.
- Storage Conditions:
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
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 -
INGREDIENTS AND APPEARANCE
ANIMI-3
folic acid, cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent, phytosterols capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66213-543 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 1000 [iU] Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 12.5 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 500 ug Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids 500 mg Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 250 mg Icosapent (UNII: AAN7QOV9EA) (Icosapent - UNII:AAN7QOV9EA) Icosapent 35 mg Soy Sterol (UNII: PL360EPO9J) (Soy Sterol - UNII:PL360EPO9J) Soy Sterol 200 mg Inactive Ingredients Ingredient Name Strength Ascorbic Acid (UNII: PQ6CK8PD0R) Alpha-Tocopherol (UNII: H4N855PNZ1) Ascorbyl Palmitate (UNII: QN83US2B0N) Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Titanium Dioxide (UNII: 15FIX9V2JP) FD&C Red No. 40 (UNII: WZB9127XOA) Water (UNII: 059QF0KO0R) Lecithin, Soybean (UNII: 1DI56QDM62) FD&C Yellow No. 6 (UNII: H77VEI93A8) Product Characteristics Color orange Score no score Shape OVAL (Capsule) Size 20mm Flavor Imprint Code Animi;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66213-543-60 60 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 Business Operations International Vitamin Corporation 964464114 manufacture(66213-543)