Label: ZATEAN-PN PLUS- levomefolate calcium, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule
- NDC Code(s): 13811-582-30
- Packager: Trigen Laboratories, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated May 3, 2013
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- HEALTH CLAIM
Zatean™ - Pn Plus is a prescription prenatal/postnatal multivitamin/ mineral softgel with an essential fatty acid. Each softgel capsule is oblong, green and imprinted with "T582" in white ink.
Servings per Bottle: 30
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains
%DV for Pregnant and
Folate (L-methylfolate, or 6(S)-5-MTHF 600 mcg) folic acid, USP 400 mcg) 1 mg 125% Vitamin C 85 mg 142% Vitamin D3 200 IU 50% Vitamin E 10 IU 33% Vitamin B6 25 mg 1000% Vitamin B12 12 mcg 150% Biotin 250 mcg 83% Calcium (calcium carbonate) 140 mg 11% Iron (ferrous fumarate) 28 mg 156% Iodine (potassium iodide) 150 mcg 100% Magnesium (magnesium oxide) 45 mg 10% Docosahexaenoic Acid (DHA) 300 mg* † Eicosapentaenoic Acid (EPA) 40 mg* †
Inactive Ingredients: Caramel, Citric Acid, Ethyl Vanillin, FD&C Blue # 1, FD&C Yellow # 5, Gelatin, Glycerin, Lecithin, Natural Creamy Orange Flavor, Purified Water, Sorbitol, Titanium Dioxide, Tripotassium Citrate, Yellow Bees Wax.Close
- INDICATIONS AND USAGE
Zatean™ - Pn Plus is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.Close
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.Close
Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids - including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
THIS PRODUCT CONTAINS SOY AND FISH OIL.Close
Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.Close
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
- PATIENT INFORMATION
Zatean™ - Pn Plus is a prescription vitamin for use only under the direction and supervision of a licensed physician.Close
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Drugs which may interact with folate include:
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the levels of this AED in the blood and allowing breakthrough seizures to occur.
- Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
- Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
- Colestipol: Reduces folic acid absorption and reduces serum folate levels.
- Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
- Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
- Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
- Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
- Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
- Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
- Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
- Smoking and alcohol: Reduced serum folate levels have been noted.
- Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
- Metformin treatment in patients with type 2 diabetes decreases serum folate.
- Warfarin can produce significant impairment in folate status after a 6 - month therapy.
- ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.Close
- DOSAGE AND ADMINISTRATION
Before, during, and or after pregnancy, one tablet daily or as prescribed by a physician.Close
- HOW SUPPLIED
Zatean™ - Pn Plus is dispensed in bottles of 30 softgels.
PRODUCT CODE 13811-582-30Close
KEEP OUT OF REACH OF CHILDRENClose
- HEALTH CLAIM
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
- PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
- INGREDIENTS AND APPEARANCE
levomefolate calcium, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent, and icosapent capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-582 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 600 ug folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) folic acid 400 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 85 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 200 [iU] .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 10 [iU] PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin 250 ug calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) calcium carbonate 140 mg ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 28 mg potassium iodide (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) potassium iodide 150 ug magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) magnesium oxide 45 mg Doconexent (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) Doconexent 300 mg Icosapent (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) Icosapent 40 ug Inactive Ingredients Ingredient Name Strength caramel (UNII: T9D99G2B1R) citric acid monohydrate (UNII: 2968PHW8QP) ethyl vanillin (UNII: YC9ST449YJ) FD&C Blue no. 1 (UNII: H3R47K3TBD) FD&C Yellow no. 5 (UNII: I753WB2F1M) gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) lecithin, soybean (UNII: 1DI56QDM62) water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) titanium dioxide (UNII: 15FIX9V2JP) potassium citrate anhydrous (UNII: 86R1NVR0HW) yellow wax (UNII: 2ZA36H0S2V) Product Characteristics Color GREEN Score no score Shape OVAL (oblong) Size 26mm Flavor Imprint Code T582 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:13811-582-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 05/01/2010 Labeler - Trigen Laboratories, Inc. (830479668)