ZATEAN-CH- calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule
Trigen Laboratories, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Zatean™-CH is an orally administered prenatal prescription vitamin. Zatean™-CH is a purple, oblong soft gelatin capsule imprinted with
"T583".
Each capsule contains the following Ingredients: | |
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*Folates– including reduced folates, are variant forms of Vitamin B9, or Folic Acid. †Derived from at least 281.7 mg omega-3s from at least 396.8 mg purified fish oil. |
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†Derived from at least 281.7 mg omega-3s from at least 396.8 mg purified fish oil. | |
Calcium (Calcium citrate) | 100 mg |
Iron (Carbonyl iron) | 27 mg |
Vitamin D3 (Cholecalciferol) | 400 IU |
Vitamin E (dl-alpha tocopheryl acetate) | 30 IU |
Vitamin B6 (Pyridoxine HCl) | 25 mg |
Folate * | 1 mg |
Docusate Sodium | 50 mg |
Docosahexaenoic Acid (DHA) | 250 mg † |
Inactive Ingredients
Lecithin, Soybean Oil, Yellow Beeswax, Natural Creamy Orange Flavor, Gelatin, Glycerin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1,
Ethyl Vanillin, Purified Water, and other trace excipients.
Zatean™-CH is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception,
throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.
Daily ingestion of more than 3 g 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 fish oil and soy products.
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.
Zatean™-CH is a prescription prenatal vitamin for use only under medical supervision and direction.
Drugs which may interact with folate include
Drugs which may interact with pyridoxine hydrochloride include
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.
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.
Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Contact with moisture can discolor or erode the capsule.
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
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.
Rx Only
Manufactured For:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
MADE IN CANADA
Rev. 10/10
ZATEAN-CH
calcium citrate, iron, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule |
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Labeler - Trigen Laboratories, LLC (830479668) |