SPL UNCLASSIFIED SECTION.
To report serious adverse event or obtain product information, call (210) 696-8400.lifesDHA(TM)Trademark of Martek Biosciences CorporationU.S. Patent No. 5,407,957U.S. Patent No. 5,492,938Manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX USA 78230 1355www.missionpharmacal.comCopyright (C) 2009 Mission Pharmacal Company. All rights reserved.
WARNING. Ingestion of more than grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 30 Capsule Bottle Carton. The one-pill solution for gentle prenatal nutritionRx Only NDC 0178-0812-05CitraNatal(R) Harmony(TM)Rx Prenatal Vitamin Gel CapConvenient, one-dose prenatal nutrition in vanilla-scented gel cap Gentle calcium citrate and carbonyl iron, plus stool softener and natural, plant-based DHAlifesDHA (TM) HEALTHY BRAIN, EYES, HEART5-DAY STARTER PACKIn Child-Resistant PackagingSample-Not For SaleContains Stool SoftenerMission(R)PHARMACAL. Convenient, one-dose prenatal nutrition in vanilla-scented gel cap Gentle calcium citrate and carbonyl iron, plus stool softener and natural, plant-based DHA. PRINCIPAL DISPLAY PANEL 30 Capsule Bottle Carton.
PRECAUTIONS. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed gram (1000 mg) per day.
BOXED WARNING SECTION.
WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.
CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION. CitraNatal(R) Harmony(TM) is prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is purple, opaque soft gelatin capsule containing greenish-gray liquid to semi-solid fill. The capsule is printed 0812 in white ink.Each prenatal capsule contains:Calcium (Calcium citrate)100 mgVitamin B6 (Pyridoxine HCl)25 mgIron (Carbonyl iron)27 mgFolic Acid1 mgVitamin D3 (Cholecalciferol)400 IUDocusate Sodium50 mgVitamin (dl-alpha tocopheryl acetate)30 IUDocosahexaenoic Acid (DHA)250 mgDHA is contained in the oil derived from microalgae.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One capsule daily or as directed by physician.Store at controlled room temperature.NOTICE: Contact with moisture can discolor or erode the capsule.
HOW SUPPLIED SECTION.
HOW SUPPLIED. Bottles of 30 capsules each NDC 0178-0812-30.
INDICATIONS & USAGE SECTION.
INDICATIONS. CitraNatal(R) Harmony(TM) is 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.