CitraNatal Assure

Mission Pharmacal Company

CitraNatalAssure 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
• CAUTION
• CITRANATAL ASSURE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton

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 "0893" on one side and is blank on the other. The essential fatty acid DHA capsule is clear and contains an amber to light/dark orange semi-solid mixture.

DHA is contained in the oil derived from microalgae.

Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.

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.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

CITRANATAL ASSURE DOSAGE AND ADMINISTRATION

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

Store at controlled room temperature.

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.

50289
C02 Rev 010090

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.

PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton

Rx Only
NDC 0178-0893-30

Its gentle nature
is its strength

CitraNatalAssure _®

Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

An Rx prenatal
vitamin and
omega-3 (DHA)
derived from an
all natural
plant source

march of dimes ^®

Mission Pharmacal is a proud
supporter of the March of Dimes.*

CONTAINS
Six 5-day Blister Packs

Mission ^®
PHARMACAL