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

CitraNatal Harmony by

Drug Labeling and Warnings

CitraNatal Harmony by is a Prescription medication manufactured, distributed, or labeled by MISSION PHARMACAL COMPANY, Accucaps Industries Ltd., Mission Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 "0812" in white ink.

Each prenatal capsule contains:

Calcium (Calcium citrate)	100 mg		Vitamin B6 (Pyridoxine HCl)	25 mg
Iron (Carbonyl iron)	27 mg		Folic Acid	1 mg
Vitamin D3 (Cholecalciferol)	400 IU		Docusate Sodium	50 mg
Vitamin E (dl-alpha tocopheryl acetate)	30 IU		Docosahexaenoic 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.

BOXED WARNING

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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 0178-0812-30.

SPL UNCLASSIFIED SECTION

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

www.missionpharmacal.com

Copyright © 2009 Mission Pharmacal Company. All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

The one-pill solution
for gentle prenatal nutrition

Rx Only
NDC 0178-0812-05

CitraNatal® Harmony™
Rx Prenatal Vitamin Gel Cap

• Convenient, one-dose prenatal nutrition
  in a vanilla-scented gel cap
   
• Gentle calcium citrate and carbonyl iron,
  plus a stool softener and natural,
  plant-based DHA

life'sDHA ™
HEALTHY BRAIN, EYES, HEART

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

Contains
Stool Softener

Mission®
PHARMACAL

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 0178-0812
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Calcium citrate (UNII: MLM29U2X85) (Calcium - UNII:SY7Q814VUP)	Calcium citrate	100 mg
Iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron - UNII:E1UOL152H7)	Iron pentacarbonyl	27 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
Alpha-tocopherol, DL- (UNII: 7QWA1RIO01) (Alpha-tocopherol, DL- - UNII:7QWA1RIO01)	Alpha-tocopherol, DL-	30 [iU]
Pyridoxine hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine hydrochloride	25 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG)	Docusate Sodium	50 mg
Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC)	Doconexent	250 mg

Product Characteristics
Color	PURPLE (opaque)	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	812
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0812-30	1 in 1 CARTON
1		30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		04/27/2010

Labeler - MISSION PHARMACAL COMPANY (008117095)

Establishment
Name	Address	ID/FEI	Business Operations
Accucaps Industries Ltd.		248441727	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	MANUFACTURE