Citranatal Assure Kit
FDA Label NDC 0178-0891

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mission Pharmacal Company for the product Citranatal Assure (NDC 0178-0891). 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.

Label Section Quick Index

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.

Each prenatal capsule contains:
Vitamin C (Ascorbic acid)120  mg
Calcium (Calcium citrate)124mg
Iron (Carbonyl iron, ferrous gluconate)35  mg
Vitamin D 3 (Cholecalciferol) 400  IU
Vitamin E (dl-alpha tocopheryl acetate)30  IU
Thiamin (Vitamin B 1) 3  mg
Riboflavin (Vitamin B 2) 3.4  mg
Niacinamide (Vitamin B 3) 20  mg
Vitamin B 6 (Pyridoxine HCl) 25  mg
Folic Acid1  mg
Iodine (Potassium iodide)150  mcg
Zinc (Zinc oxide)25  mg
Copper (Cupric oxide)2  mg
Docusate Sodium50  mg
Each DHA gelatin capsule contains:
Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)300  mg
Eicosapentaenoic Acid (EPA)Not more than 0.750  mg

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.

Contraindications

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

Warning

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.

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

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

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.

Other

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.

Package Label.Principal Display Panel

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

Citra-natal-assure-carton-0178-0891-30 (Citra Natal Assure Carton 0178 0891 30)

Citra-natal-assure-carton-0178-0891-30 (Citra Natal Assure Carton 0178 0891 30)

* Please review the disclaimer below.