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CitraNatal Harmony

Generic Name: calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent
Dosage Form: capsule, gelatin coated

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Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

CitraNatal Harmony®
Rx Prenatal Vitamin
Gel Cap

Rx Only

CitraNatal Harmony Description

CitraNatal Harmony® is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed "0798" in white ink.

Each prenatal capsule contains:

Calcium (Calcium citrate) 104  mg
Iron (Carbonyl iron) 30  mg
Vitamin D3 (Cholecalciferol) 400  IU
Vitamin E (dl-alpha tocopheryl acetate) 30  IU
Vitamin B6 (Pyridoxine HCl) 25  mg
Folic Acid 1  mg
Docusate Sodium 50  mg
Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil) 260  mg

INDICATIONS

CitraNatal Harmony® 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.

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.

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 Harmony Dosage and Administration

One capsule daily or as directed by a physician.

Store at controlled room temperature.

NOTICE: Contact with moisture can discolor or erode the capsule.

How is CitraNatal Harmony Supplied

Bottles of 30 capsules each - NDC 0178-0798-30.

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

life'sDHA™

Trademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
U.S. Patent No. 5,492,938

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

Copyright © 2011 Mission Pharmacal Company.
All rights reserved.

MADE IN CANADA

L079830 C01 Rev 009110

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 0178-0798-30

Rx Only

CitraNatal Harmony®

Rx Prenatal Vitamin
Gel Cap

30 Capsules

march of dimes®

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

Mission®
PHARMACAL

CitraNatal Harmony 
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0798
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium citrate (Calcium) Calcium citrate 104 mg
Iron pentacarbonyl (Iron) Iron pentacarbonyl 30 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
.Alpha.-Tocopherol, Dl- (.Alpha.-Tocopherol, Dl-) .Alpha.-Tocopherol, Dl- 30 [iU]
Pyridoxine hydrochloride (Pyridoxine) Pyridoxine hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Docusate Sodium (Docusate) Docusate Sodium 50 mg
Doconexent (Doconexent) Doconexent 260 mg
Product Characteristics
Color PURPLE (opaque) Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 0798
Contains     
Packaging
# Item Code Package Description
1 NDC:0178-0798-30 1 BOTTLE (BOTTLE) in 1 CARTON
1 30 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/15/2012
Labeler - MISSION PHARMACAL COMPANY (008117095)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Ltd. 248441727 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Mission Pharmacal Company 927726893 MANUFACTURE
Revised: 01/2012
 
MISSION PHARMACAL COMPANY
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