BOXED WARNING SECTION.
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS 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 - Blister Pack Carton Rx Only NDC 0178-0832-30 The gentle option for additional B 6 CitraNatal B- Calm Rx Prenatal Vitamin and two 25 mg each Vitamin B 6 tablets A prescription prenatal supplement with 1 mg of folic acid and a high level of vitamin B 6 which may act as an antiemetic. march of dimes Mission Pharmacal is a proud supporter of the March of Dimes.* Mission PHARMACAL CONTAINS Six 5-day Blister Packs
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
INDICATIONS CitraNatal B-Calm 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. CitraNatal B-Calm may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION One tablet every eight hours, beginning with "Tablet 1", or as directed by a physician. Store at controlled room temperature. NOTICE: Contact with moisture can discolor or erode tablets.
SPL UNCLASSIFIED SECTION.
To report a serious adverse event or obtain product information, call (210) 696-8400. 50310 C01 Rev 008110 Mission PHARMACAL DHA capsules manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 www.missionpharmacal.com Copyright 2009 Mission Pharmacal Company. All rights reserved. Ferr-Ease Dual-iron delivery Trademark of Mission Pharmacal Company U.S. Patent No. 6,521,247 life's DHA HEALTHY BRAIN, EYES, HEART Trademark of Martek Biosciences Corporation U.S. Patent No. 5,407,957 U.S. Patent No. 5,492,938 *March of Dimes does not endorse specific products or brands. March of Dimes is a registered trademark of the March of Dimes Foundation.
HOW SUPPLIED SECTION.
HOW SUPPLIED Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B 6 tablets each - NDC 0178-0832-30.
DESCRIPTION CitraNatal B-Calm is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6 tablets. The prenatal tablet contains Ferr-Ease , a patented dualiron delivery comprising both a quick release and slow release iron. The prenatal tablet is white, coated, modified oval, and is debossed with "0832" on one side and is blank on the other. The B 6 25 mg tablets are white to off-white, uncoated, round, and are debossed with "B" on one side and "6" on the other. Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 120 mg Iron (Carbonyl iron, Ferrous gluconate) 20 mg Vitamin D 3 (Cholecalciferol) 400 IU Vitamin B 6 (Pyridoxine HCl) 25 mg Folic Acid 1 mg Each vitamin B 6 tablet contains: Vitamin B 6 (Pyridoxine HCl) 25 mg
PRECAUTION Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
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 B 12 is deficient.