Zatean-Pn DHA: Package Insert and Label Information

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, LLC

SUPPLEMENT FACTS

Zatean Pn DHA Supplement Facts Panel Rev. 07/2019
(click image for full-size original)

Other Ingredients: Gelatin Capsule (Bovine gelatin, glycerin, purified water, sorbitol, ethyl vanillin, titanium dioxide, FD&C Yellow #5, FD&C Blue #1), yellow beeswax, soybean oil, soy lecithin, natural & artificial orange cream flavor, citric acid, potassium citrate


THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).


Zatean™- Pn DHA 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 products.

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.

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

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 DHA is an oblong shaped, dark green soft gelatin capsule containing brown paste, laser etched with white “T580”.

DIRECTIONS FOR USE

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

HOW SUPPLIED

Zatean™ — Pn DHA is dispensed in bottles of 30 softgel capsules.

PRODUCT CODE 13811-580-30

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

Trigen Logo

PRINCIPAL DISPLAY PANEL — 30 Softgel Bottle Label

13811-580-30

Zatean™-Pn DHA
Softgels

30 SOFTGELS

TRIGEN
LABORATORIES

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

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 Type Item Code (Source) NDC:13811-580
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
calcium carbonate (CARBONATE ION) calcium carbonate 140 mg
ferrous fumarate (FERROUS CATION) FERROUS CATION 27 mg
magnesium oxide (MAGNESIUM CATION) magnesium oxide 45 mg
Doconexent (DOCONEXENT) Doconexent 300 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN TYPE B BOVINE (160 BLOOM)
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
SORBITOL
LECITHIN, SOYBEAN
Product Characteristics
Color GREEN Score no score
Shape OVAL (Oblong) Size 26mm
Flavor ORANGE (creamy) Imprint Code T580
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13811-580-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 04/01/2010
Labeler — Trigen Laboratories, LLC (830479668)

Revised: 05/2020 Trigen Laboratories, LLC

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