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CitraNatal Harmony Prescribing Information

Package insert / product label
Generic name: calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium and doconexent
Dosage form: capsule, gelatin coated
Drug classes: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Rx Only

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.

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 Acid1 mg
Docusate Sodium50 mg
Docosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)260 mg

Indications and Usage for CitraNatal Harmony

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.

Warnings

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.

Warnings

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/Side Effects

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

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

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
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:0178-0798
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium citrate (UNII: MLM29U2X85) (Calcium - UNII:SY7Q814VUP) Calcium citrate104 mg
Iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron - UNII:E1UOL152H7) Iron pentacarbonyl30 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) Doconexent260 mg
Product Characteristics
ColorPURPLE (opaque) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code0798
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0798-301 in 1 CARTON
130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/15/2012
Labeler - MISSION PHARMACAL COMPANY (008117095)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries Ltd.248441727MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE