INDICATIONS & USAGE SECTION.
INDICATIONS. CitraNatal Harmony (R) 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
CitraNatal Sample Carton NDC 0178-0797-06 sample-carton-0178-0797-06.
PRECAUTIONS. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
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.WARNINGFolic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin 12 is deficient.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One capsule daily or as directed by physician.Store at controlled room temperature.NOTICEContact with moisture can discolor or erode the capsule.
HOW SUPPLIED SECTION.
HOW SUPPLIED. Bottles of 30 capsules each -- NDC 0178-0797-30To report serious adverse event or obtain product information, call (210) 696-8400Please consult your health care provider with any dietary concerns.Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.CAUTIONExercise 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 contraindictated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION. CitraNatal Harmony (R) 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 0797 in white ink. Each prenatal capsule contains:Calcium (Calcium citrate)104 mgVitamin 6 (Pyridoxine HCI) 25 mgIron (Carbonyl iron) 29 mgFolic Acid mgVitamin 3 (Cholecalciferol) 400 UDocusate Sodium 50 mgVitamin (d-alpha tocopheryl acetate) 30 UDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)265 mg.