CitraNatal Assure

Mission Pharmacal Company
Mission Pharmacal Company

CitraNatal Assure Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

FULL PRESCRIBING INFORMATION: CONTENTS*

• CITRANATAL ASSURE DESCRIPTION
• INDICATIONS
• CITRANATAL ASSURE CONTRAINDICATIONS
• WARNING
• WARNING
• PRECAUTIONS
• CITRANATAL ASSURE ADVERSE REACTIONS
• CITRANATAL ASSURE DOSAGE AND ADMINISTRATION
• STORAGE
  • NOTICE
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

CITRANATAL ASSURE DESCRIPTION

CitraNatal Assure^® is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease^®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

INDICATIONS

CitraNatal Assure^® 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 ASSURE CONTRAINDICATIONS

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

WARNING

Ingestion of more than 3 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.

WARNING

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

PRECAUTIONS

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

CITRANATAL ASSURE ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

CITRANATAL ASSURE DOSAGE AND ADMINISTRATION

One tablet and one capsule daily or as directed by a physician.

STORAGE

Store at 20–25°C (68–77°F)

NOTICE

Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0893-30

To report a serious adverse event or obtain product information, call (210) 696-8400.

51062
C01 Rev 010130

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

Copyright © 2013 Mission Pharmacal Company.

All rights reserved.

www.missionpharmacal.com

Ferr-Ease ^®
Dual-iron delivery

Trademark of Mission Pharmacal Company
U.S. Patent No. 6,521,247

life's DHA ^®

life’sDHA is a trademark of DSM.
U.S. Patent No. 7,579,174
U.S. Patent No. 7,732,170
U.S. Patent No. 5,518,918

*March of Dimes does not endorse
specific products or brands.
March of Dimes is a registered trademark
of the March of Dimes Foundation.

CitraNatal Assure Sample Blister Pack
NDC 0178–0891–10

5-Day Sample Pack Carton

6-Count Sample Pack Display

CitraNatal Assure Retail Blister Pack
NDC 0178–0891–30

Retail Carton