Zatean-Pn Plus: Package Insert and Label Information

ZATEAN-PN PLUS- levomefolic acid, folic acid, ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, doconexent and icosapent capsule
Trigen Laboratories, LLC

SUPPLEMENT FACTS

Zatean-Pn Plus Supplement Facts Panel Rev. 06/2019
(click image for full-size original)

Other Ingredients: Orange Cream Flavor O.S., Citric Acid, Biomin Potassium Citrate, Soy Lecithin, Yellow Beeswax

Shell Ingredients: Bovine Gelatin, Glycerin, Purified Water, Sorbitol, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #5, FD&C Blue #1, and Caramel.


THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).

Zatean™-Pn Plus is a prescription prenatal/postnatal multivitamin/ mineral softgel with an essential fatty acid and 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 soy or fish oil.

WARNING

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.

PRECAUTIONS

General: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

DRUG 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.

There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

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.

DESCRIPTION

Zatean™ — Pn Plus is an oblong shaped, dark green soft gelatin capsule containing brown paste with white “T582” laser etched.

DIRECTIONS FOR USE

Take one softgel capsule by mouth daily or as prescribed by a physician.

HOW SUPPLIED

Zatean™ — Pn Plus is available in bottles of 30 softgel capsules.

PRODUCT CODE 13811-582-30

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088.

Rev. 05/2020

Customer Service: 1-877-482-3788

Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807
www.trigenlab.com

TRIGENLOGO

PRINCIPAL DISPLAY PANEL — 30 Softgel Bottle Label

13811-582-30

Zatean-Pn Plus
Softgels

30 SOFTGELS

Zatean-Pn Plus Bottle Label
(click image for full-size original)
Zatean-Pn Plus Bottle Label
(click image for full-size original)

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
Product Information
Product Type Item Code (Source) NDC:13811-582
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 600 ug
folic acid (FOLIC ACID) folic acid 400 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 85 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 10 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
Biotin (Biotin) Biotin 250 ug
calcium carbonate (CALCIUM CATION) calcium carbonate 140 mg
ferrous fumarate (FERROUS CATION) FERROUS CATION 28 mg
potassium iodide (IODIDE ION) potassium iodide 150 ug
magnesium oxide (MAGNESIUM CATION) magnesium oxide 45 mg
Doconexent (DOCONEXENT) Doconexent 300 mg
Icosapent (ICOSAPENT) Icosapent 40 mg
Inactive Ingredients
Ingredient Name Strength
caramel
ethyl vanillin
FD&C Blue no. 1
FD&C Yellow no. 5
gelatin
glycerin
lecithin, soybean
water
sorbitol
titanium dioxide
potassium citrate anhydrous
yellow wax
ANHYDROUS CITRIC ACID
ORANGE OIL
Product Characteristics
Color GREEN Score no score
Shape OVAL (oblong) Size 26mm
Flavor Imprint Code T582
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13811-582-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 05/01/2010
Labeler — Trigen Laboratories, LLC (830479668)

Revised: 05/2020 Trigen Laboratories, LLC

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