CITRANATAL HARMONY - calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated 
MISSION PHARMACAL COMPANY

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.

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CitraNatal Harmony®
Rx Prenatal Vitamin Gel Cap

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 "0799" in white ink.

Each prenatal capsule contains:

Calcium (Calcium citrate)100 mgVitamin B6 (Pyridoxine HCl)25 mg
Iron (Carbonyl iron)28 mgFolic Acid1 mg
Vitamin D3 (Cholecalciferol)400 IUDocusate Sodium50 mg
Vitamin E (dl-alpha tocopheryl acetate)30 IUDocosahexaenoic Acid (DHA)250 mg

DHA is contained in the oil derived from microalgae.

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.

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 SUPPLIED

Bottles of 30 capsules each - NDC 0178-0799-30.

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. 5,407,857
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.

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

www.missionpharmacal.com

Copyright © 2011 Mission Pharmacal Company. All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

The one-pill solution
for gentle prenatal nutrition

Rx Only
NDC
0178-0799-05

CitraNatal Harmony®
Rx Prenatal Vitamin Gel Cap
 

life'sDHA ™
HEALTHY BRAIN, EYES, HEART

5-DAY STARTER PACK
In Child-Resistant Packaging
Sample–Not For Sale

Contains
Stool Softener

Working together for stronger, healthier babies

Mission®
PHARMACAL

march of dimes

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

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton
CITRANATAL HARMONY 
calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0799
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium citrate (UNII: MLM29U2X85) (Calcium - UNII:SY7Q814VUP) Calcium citrate100 mg
Iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron - UNII:E1UOL152H7) Iron pentacarbonyl28 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
.Alpha.-tocopherol, DL- (UNII: 7QWA1RIO01) (.Alpha.-tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-tocopherol, DL-30 [iU]
Pyridoxine hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine hydrochloride25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium50 mg
Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent250 mg
Product Characteristics
ColorPURPLE (opaque) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code 812
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0799-051 in 1 CARTON
15 in 1 BOTTLE
2NDC:0178-0799-301 in 1 CARTON
230 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/18/2011
Labeler - MISSION PHARMACAL COMPANY (008117095)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries Ltd.248441727MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE

Revised: 6/2011
Document Id: 779591fd-fd24-40fe-870f-df1f1c914b22
Set id: bd9ebd35-481b-4e9d-8c14-d47b27a4b561
Version: 1
Effective Time: 20110603
 
MISSION PHARMACAL COMPANY