BOXED WARNING SECTION.
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label NDC 0178-0798-30 Rx Only CitraNatal Harmony Rx Prenatal Vitamin Gel Cap 30 Capsules march of dimes Mission Pharmacal is a proud supporter of the March of Dimes.* Mission PHARMACAL
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 1 gram (1000 mg) per day.
INDICATIONS & USAGE SECTION.
INDICATIONS CitraNatal Harmony is a 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.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION One capsule daily or as directed by a physician.
SPL UNCLASSIFIED SECTION.
To report a serious adverse event or obtain product information, call (210) 696-8400. life'sDHA Trademark of Martek Biosciences Corporation U.S. Patent No. 5,407,957 U.S. Patent No. 5,492,938 Manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Copyright 2011 Mission Pharmacal Company. All rights reserved. MADE IN CANADA L079830 C01 Rev 009110
HOW SUPPLIED SECTION.
HOW SUPPLIED Bottles of 30 capsules each - NDC 0178-0798-30.
DESCRIPTION CitraNatal Harmony is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed "0798" in white ink. Each prenatal capsule contains: Calcium (Calcium citrate) 104 mg Iron (Carbonyl iron) 30 mg Vitamin D3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Vitamin B6 (Pyridoxine HCl) 25 mg Folic Acid 1 mg Docusate Sodium 50 mg Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil) 260 mg
PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
STORAGE AND HANDLING SECTION.
Store at controlled room temperature. NOTICE: Contact with moisture can discolor or erode the capsule.
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.