WARNINGS SECTION.
WARNING: Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEPTHIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.
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DRUG INTERACTIONS SECTION.
DRUG INTERACTIONS: C-NATE DHA softgels are not recommended for and should not be given to patients receiving levodopa because the actionof levodopa is antagonized by pyridoxine.
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GERIATRIC USE SECTION.
GERIACTRIC USE: No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly person may have decreased hepatic, renal, or cardiac function.
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HOW SUPPLIED SECTION.
HOW SUPPLIED: C-NATE DHA is available as Annato colored softgel, imprinted PRE 01. Available in 30 count bottles with NDC 23359-105-30 and samples with NDC 23359-105-05 and NDC 23359-105-01. PHYSICIAN SAMPLE NOT FOR RESALE.
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INACTIVE INGREDIENT SECTION.
INACTIVE INGREDIENTS: Gelatin, Glycerol, beeswax yellow, lecithin, water-purified and colorant.
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INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE: C-NATE DHA is prescription multivitamin/multimineral 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.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. NDC 23359-105-30C-Nate DHA SoftgelsOmega-3 Fatty Acids (DHA-EPA)200mgVitamin 1 (Thiamine Mononitrate) mgVitamin 2 (Riboflavin) mgVitamin 6 (Pyridoxine HCL) 20 mgVitamin 12 (Cyanocobalamin) 15 mcgFolic Acid1 mgVitamin 3 (Cholecalciferol) 400 IUVitamin (Ascorbic Acid)100 mgVitamin (d-alpha tocopherol)30 IUCopper (Cupric Sulfate)1 mgZinc (Zinc Oxide)20 mgIron (Fumerate)28 mgMagnesium30 mg Rx OnlyNet Contents: 30 softgelsManufactured For:Centurion Labs LLC Distributed by: Centurion Labs LLC Birmingham, AL 35243 PRINCIPAL DISPLAY PANEL 30 tablets.
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PEDIATRIC USE SECTION.
PEDIATRIC USE: Safety and effectiveness in pediactric patients has not been established.
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PRECAUTIONS SECTION.
PRECAUTIONS: Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemiaswhere vitamin 12 is deficient. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestationsprogress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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SPL UNCLASSIFIED SECTION.
PRENATAL MULTIVITAMINRev. 10/12Rx ONLY.
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STORAGE AND HANDLING SECTION.
Recommended Storage: 15-30C (59-86F) degrees. Protect from light moisture and avoid excessive heat. Dispense original carton. KEEP OUT OF REACH OF CHILDRENRX ONLY.
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ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, hasbeen associated with gastrointestinal intolerance in some patients.
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CONTRAINDICATIONS SECTION.
CONTRAINDICATIONS: C-NATE DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients.
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DESCRIPTION SECTION.
Description:.
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DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Usual adult dose: one softgel daily or as prescribed by your doctor.
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