The following Structured Product Label (SPL) was submitted to the FDA by Mission Pharmacal Company for the product Citranatal Essence (NDC 0178-0864). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications, contraindications, warning, precautions, adverse reactions, dosage and administration, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
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.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
One tablet and one capsule daily or as directed by a physician.
Store at 20–25°C (68–77°F)
Contact with moisture can discolor or erode the tablet.
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
Copyright © 2020 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.
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0864-30
Retail Carton
* Please review the disclaimer below.
