Zatean-Pn DHA (levomefolic acid 600 ug folic acid 400 ug ascorbic acid 85 mg cholecalciferol 200 [iu] .alpha.-tocopherol 10 [iu] pyridoxine 25 mg cyanocobalamin 12 ug calcium carbonate 140 mg ferrous fumarate 27 mg magnesium oxide 45 mg doconexent 300 mg) Dailymed
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Supplement Facts
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].
Health Claim Section
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, LLCBridgewater, NJ 08807
Principal Display Panel - 30 Softgel Bottle Label
13811-580-30
Zatean™-PnDHA Softgels
30 SOFTGELS
TRIGEN LABORATORIES
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