Your browser does not support JavaScript! ZATEAN-PN DHA (LEVOMEFOLIC ACID, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, AND DOCONEXENT) CAPSULE [TRIGEN LABORATORIES, INC.]
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ZATEAN-PN DHA (levomefolic acid, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent) capsule
[Trigen Laboratories, Inc.]


Category DEA Schedule Marketing Status
DIETARY SUPPLEMENT Dietary Supplement
Drug Label Sections

DESCRIPTION

Zatean™ - Pn DHA is a prescription prenatal/postnatal multivitamin/mineral softgel with an essential fatty acid. Zatean™ - Pn DHA are green, oblong softgels imprinted with "T580."

Supplement Facts
Servings per Bottle: 30
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains
%DV for Pregnant and
Lactating Women
*
from at least 330 mg purified fish oils.
Daily value not established. THIS PRODUCT CONTAINS SOY AND FISH OIL.
Folate (L-methylfolate, or 6(S)-5-MTHF-Ca 600 mcg) folic acid, USP 400 mcg)1 mg125%
Vitamin C85 mg142%
Vitamin D3200 IU50%
Vitamin E10 IU33%
Vitamin B625 mg1000%
Vitamin B1212 mcg150%
Calcium (calcium carbonate)140 mg11%
Iron (ferrous fumarate)27 mg150%
Magnesium (magnesium oxide)45 mg10%
Docosahexaenoic Acid (DHA)300 mg*

Inactive Ingredients: Gelatin, Glycerin, Soybean Oil, Purified Water, Yellow Beeswax, Lecithin, Natural Creamy Orange Flavor, Titanium Dioxide, TriPotassium Citrate, Citric Acid, Ethyl Vanillin, FD&C Yellow #5, and FD&C Blue #1

INDICATIONS AND USAGE

Zatean™ - Pn DHA is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.

WARNING

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.

THIS PRODUCT CONTAINS SOY AND FISH OIL.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

PRECAUTIONS

General

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 DHA is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

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.

DOSAGE AND ADMINISTRATION

Before, during, and or after pregnancy, one tablet daily or as prescribed by a physician.

HOW SUPPLIED

Zatean™ - Pn DHA is dispensed in bottles of 30 softgels.

PRODUCT CODE 13811-580-30

KEEP OUT OF REACH OF CHILDREN

Rx Only

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.

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 02/13

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

13811-580-30

Rx Only

Zatean-Pn
DHA

Softgels

30 SOFTGELS

TRIGEN
LABORATORIES

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
ZATEAN-PN DHA 
levomefolic acid, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide, and doconexent capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-580
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Levomefolic Acid (LEVOMEFOLIC ACID) Levomefolic Acid600 ug
Folic acid (FOLIC ACID) Folic acid400 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID85 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL200 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL10 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN12 ug
calcium carbonate (CARBONATE ION) calcium carbonate140 mg
ferrous fumarate (FERROUS CATION) FERROUS CATION27 mg
magnesium oxide (MAGNESIUM CATION) magnesium oxide45 mg
Doconexent (DOCONEXENT) Doconexent300 mg
Inactive Ingredients
Ingredient NameStrength
gelatin 
glycerin 
soybean oil 
water 
yellow wax 
titanium dioxide 
potassium citrate anhydrous 
citric acid monohydrate 
ethyl vanillin 
FD&C yellow no. 5 
FD&C blue no. 1 
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (Oblong) Size26mm
FlavorORANGE (creamy) Imprint Code T580
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-580-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT04/01/2010
Labeler - Trigen Laboratories, Inc. (830479668)

Revised: 4/2013
 
Trigen Laboratories, Inc.

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