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Concept DHA™
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Inactive Ingredients: Gelatin, Glycerol Monostearate, Mixed Tocopherols, Titanium Dioxide, FD&C Blue 1, FD&C Red 3, FD&C Red 40, FD&C Blue 2, Ethylcellulose, Ammonium Hydroxide, Medium Chain Triglycerides, Oleic Acid, Sodium Alginate, and Purified Stearic Acid.
Indications
Tandem® DHA is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Tandem® DHA may also be used to improve the nutritional status of women before conception.
Contraindications
Tandem® DHA is contraindicated in patients with known hypersensitivity to any of its ingredients, including fish or fish oil; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
Dosage
Adults (persons over 12 years of age), one (1) capsule daily, orally, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.
How Supplied
Tandem® DHA are opaque pink capsules imprinted "Tandem® DHA": Child resistant bottles of 90 capsules NDC# 52747-904-60. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15° to 30°C (59° to 86° F). Keep in a cool, dry place. Capsules are not USP.
Warnings
WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
Caution
Rx only.
This product information is intended for the physician and is not the entire product information. Please download the product literature for the complete product information.
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