daybreak Se-Tan DHA Generic Name: ferrous fumarate and polysaccharide iron Dosage Form: capsule, gelatin coated Side Effects Dosage Professional Interactions Reviews More 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. Ferrous Fumarate/Polysaccharide Iron Complex Vitamin Mineral Complex Prenatal Soft Gel Capsules With DHA R x Only DESCRIPTION: Each dark blue liquid filled soft gel capsule contains: Ferrous Fumarate (Elemental Iron) 15 mg Polysaccharide Iron Complex (Elemental Iron) (Equivalent to about 30 mg of elemental iron) 15 mg Vitamin C (Sodium Ascorbate) 20 mg Folic Acid 1 mg Vitamin B6 (Pyridoxine HCI) 25 mg Omega-3 Fatty Acids (Derived from at least 450 mg Fish Oil) 310.1 mg Docosahexaenoic Acid (DHA) 215.12 mg Eicosapentaenoic Acid (EPA) 53.46 mg Inactive Ingredients: Bovine Gelatin, Ethyl Vanillin, FD&C Blue, FD&C Yellow #3, Glycerin, Natural Creamy Orange Flavor, Purified Water, Sodium Citrate, Soy Lecithin, Soybean Oil, Titanium Dioxide, Vitamin E, Yellow Bees Wax. Slideshow OTC Medication Use In Pregnancy: Wise or Worrisome? INDICATIONS: Se-Tan 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. Se-Tan DHA may also be used to improve the nutritional status of women before conception. CONTRAINDICATIONS: Se-Tan 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. WARNING: Accidental overdose of ironcontaining 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 for pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. PRECAUTIONS: General: Folic acid in doses above 0.1 mg -0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients. Geriatric Use: No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases. Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Se-Tan DHA after meals may control occasional G.I. disturbances. Se-Tan DHA is best absorbed when taken at bedtime. OVERDOSE: Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Se-Tan DHA should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of the reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen. DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) soft gel 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: Se-Tan DHA are dark blue, oblong, liquid filled soft gel capsules imprinted T513 . Child resistant bottles of 90 soft gel capsules. NDC 13925-119-90. Dispense in a tight, light resistant container as defined in the USP/NF with a child resistant closure. Storage: Store at controlled room temperature 15 -30 C (59 -86 F) [see USP Controlled Room Temperature]. Keep in a cool dry place. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN Rx Only. RESERVED FOR PROFESSIONAL RECOMMENDATION. Manufactured for: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA Iss. 06/13 SETON PHARMACEUTICALS PRINCIPAL DISPLAY PANEL: NDC 13925- 119 -90 Se-Tan-DHA Ferrous Fumarate/Polysaccharide Iron Complex Vitamin Mineral Complex Prenatal Sofgel Capsules With DHA 90 Capsules R x Only SETON PHARMACEUTICALS Se-Tan DHA ferrous fumarate and polysaccharide iron capsule, gelatin coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-119 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 15 mg IRON DEXTRAN (FERRIC CATION) FERRIC CATION 15 mg SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 20 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 25 mg OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 310.1 mg DOCONEXENT (DOCONEXENT) DOCONEXENT 215.12 mg ICOSAPENT (ICOSAPENT) ICOSAPENT 53.46 mg Inactive Ingredients Ingredient Name Strength GELATIN ETHYL VANILLIN FD&C BLUE NO. 1 PIGMENT YELLOW 138 GLYCERIN WATER SODIUM CITRATE LECITHIN, SOYBEAN SOYBEAN OIL TITANIUM DIOXIDE .ALPHA.-TOCOPHEROL YELLOW WAX Product Characteristics Color BLUE (dark blue) Score no score Shape CAPSULE Size 23mm Flavor ORANGE (creamy-orange) Imprint Code T513 Contains Packaging # Item Code Package Description 1 NDC:13925-119-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2009 04/30/2016 Labeler - Seton Pharmaceuticals (828898002) Revised: 08/2015 Seton Pharmaceuticals Next Interactions Print this page Add to My Med List More about Se-Tan DHA (multivitamin, prenatal) Side Effects Dosage Information Drug Interactions 0 Reviews Add your own review/rating Drug class: iron products Consumer resources Professional resources Other brands: Prenatal Plus , PreNexa , Prenatal 19 , Docosavit , ... +74 more Related treatment guides Vitamin/Mineral Supplementation during Pregnancy/Lactation FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Iron products Vitamin and mineral combinations Related Drugs iron products ferrous sulfate , Feosol Original , Iron-150 , Dialyvite vitamin and mineral combinations multivitamin , Citracal + D Vitamin / Mineral Supplementation during Pregnancy / Lactation ferrous sulfate , Feosol Original , Prenatal Multivitamins , Fergon , Ferrousal , FeroSul , Prenatal Plus , Slow Fe , Hemocyte , PreNexa , Prenatal 19 , Ferrocite , Stuart Prenatal with Beta Carotene , OB Complete , Docosavit , Prenatal H , CitraNatal Assure , More... Se-Tan DHA Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! because of
issue Se-Tan DHA superb
EmoticonEmoticon