CitraNatal Essence Prescribing Information

CitraNatal Essence Description

CitraNatal Essence™ is a prescription prenatal/postnatal multi-vitamin/ mineral tablet with Ferr-Ease®, a dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a white, coated, oval multi-vitamin/mineral tablet. The tablet is debossed “0864” on one side and is blank on the other. The essential fatty acid DHA soft gel is oblong, transparent, and caramel colored.

Indications and Usage for CitraNatal Essence

CitraNatal Essence TM 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.

Contraindications

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

Warnings

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.

Related/similar drugs

ferrous sulfate, FeroSul, Prenatal Multivitamins, Prenatal 19

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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.

Adverse Reactions/Side Effects

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

CitraNatal Essence Dosage and Administration

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

Storage and Handling

Store at 20–25°C (68–77°F)

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

51065R0420

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

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.

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0864-30

Retail Carton