INDICATIONS & USAGE SECTION.
INDICATIONS. CitraNatal Harmony (R) is multivitamin/mineral prescription drug indicated for use inimproving the nutritional status of women prior to conception, throughoutpregnancy, and in the postnatal period for both lactating and nonlactatingmothers.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
CitraNatal Label NDC 0178-0796-30 citranatal-harmony-30-softgels-carton.
PRECAUTIONS. Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remissioncan occur while neurological manifestations progress.
WARNING. Ingestion of more than grams of omega-3 fattyacids per day has been shown to have potential antithrombotic effects,including an increased bleeding time and INR. Administration of omega-3fatty acids should be avoided in patients on anticoagulants and inthose known to have an inherited or acquired bleeding diathesis.WARNINGFolic acid alone is improper therapyin the treatment of pernicious anemia and other megaloblastic anemiaswhere vitamin 12 is deficient.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS. Allergic sensitization has been reported followingboth oral and parenteral administration of folic acid.CAUTIONExercise caution to ensure thatthe prescribed dosage of DHA does not exceed gram (1000 mg) perday.
BOXED WARNING SECTION.
WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidentaloverdose, call doctor or poison control center immediately.
CONTRAINDICATIONS. This product is contraindictated in patientswith known hypersensitivity to any of the ingredients.
DESCRIPTION. CitraNatal Harmony (R) is prescription prenatal/postnatal multivitamin/mineral soft gelatincapsule. The prenatal vitamin is purple, opaque soft gelatin capsulecontaining greenish-gray liquid to semi-solid fill. The capsuleis printed 0796 in white ink. Each prenatal capsule contains:Calcium (Calcium citrate)104 mgVitamin 6 (Pyridoxine HCl) 25 mgIron (Ferrous fumarate, carbonyl iron) 27 mgFolic Acid mgVitamin 3 (Cholecalciferol) 400 IUDocusate Sodium 50 mgVitamin (dl-alpha tocopheryl acetate) 30 IUDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)260 mg.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One capsule daily or as directed by physician.Store at controlled room temperature.NOTICEContact with moisture can discoloror erode the capsule.
HOW SUPPLIED SECTION.
HOW SUPPLIED. Bottles of 30 capsules each NDC 0178-0796-30To report serious adverse eventor obtain product information, call (210) 696-8400Please consult your health care provider withany dietary concerns.Manufactured for: MISSIONPHARMACAL COMPANY San Antonio, TX USA 78230 1355.