Citranatal Assure
FDA Label NDC 0178-0893

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 0178-0893). 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, caution, dosage and administration, 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 "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.

Each prenatal capsule contains:
Vitamin C (Ascorbic acid)120  mg
Calcium (Calcium citrate)125  mg
Iron (Carbonyl iron, ferrous gluconate)35  mg
Vitamin D3 (Cholecalciferol)400  IU
Vitamin E (dl-alpha tocopheryl acetate)30  IU
Thiamin (Vitamin B1)3  mg
Riboflavin (Vitamin B2)3.4  mg
Niacinamide (Vitamin B3)20  mg
Vitamin B6 (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)300  mg
Eicosapentaenoic Acid (EPA)Not more than 0.750  mg

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.

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 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.

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.

Dosage And Administration

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

Storage And Handling

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

Other

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

Principal Display Panel (Six 5-day Blister Pack Carton)

Principal Display Panel (Six 5-day Blister Pack Carton)

* Please review the disclaimer below.