CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS SECTION.


WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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 www.missionpharmacal.com Copyright 2009 Mission Pharmacal Company. All rights reserved.

DESCRIPTION SECTION.


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 "0812" in white ink. Each prenatal capsule contains: Calcium (Calcium citrate) 100 mg Vitamin B6 (Pyridoxine HCl) 25 mg Iron (Carbonyl iron) 27 mg Folic Acid 1 mg Vitamin D3 (Cholecalciferol) 400 IU Docusate Sodium 50 mg Vitamin E (dl-alpha tocopheryl acetate) 30 IU Docosahexaenoic Acid (DHA) 250 mg DHA is contained in the oil derived from microalgae.

PRECAUTIONS SECTION.


PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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 Carton The one-pill solution for gentle prenatal nutrition Rx Only NDC 0178-0812-05 CitraNatal Harmony Rx Prenatal Vitamin Gel Cap Convenient, one-dose prenatal nutrition in a vanilla-scented gel cap Gentle calcium citrate and carbonyl iron, plus a stool softener and natural, plant-based DHA life'sDHA HEALTHY BRAIN, EYES, HEART 5-DAY STARTER PACK In Child-Resistant Packaging Sample-Not For Sale Contains Stool Softener 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. 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.