Zatean -Pn DHA

Suggested/Recommended/Usage/Directions

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

Storage

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

Precautions re: Children

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 re: All Other

Call your doctor about side effects. You may report side effects by calling 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-332-1088.

Precautions re: Children

Keep out of reach of children.

FDA Statement of Identity

Prenatal Dietary Supplement

Formulation re: Other

Description Zatean-Pn DHA is an oblong shaped, dark green soft gelatin capsule containing brown paste, laser etched with white "T580".

Suggested/Recommended/Usage/Directions

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

General Statements: All Other Content

How supplied Zatean-Pn DHA is dispensed in bottles of 30 softgel capsules.

General Statements: All Other Content

For use on the order of a healthcare practitioner.

Precautions re: Allergies

This product contains soy and fish oil (anchovy).

Formula re: Contains

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.

Precautions re: Allergies

Contraindications This product is contraindicate in patients with a known hypersensitivity to any of the ingredients, including soy or fish products.

Precautions re: Pregnant or Nursing or Prescription Medications

Precautions: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megalablastic 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. This patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Precautions re: Allergies

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.

Precautions re: Pregnant or Nursing or Prescription Medications

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, Clapidogrel).

Precautions re: Allergies

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.