CITRANATAL HARMONY 2.1- 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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These highlights do not include all the information needed to use CitraNatal Harmony ® safely and effectively. See full prescribing information for CitraNatal Harmony ®.

CitraNatal Harmony ® (Calcium citrate, Iron pentacarbonyl, Cholecalciferol, .Alpha.-Tocopherol, Dl-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, and Doconexent) capsules for oral use.

Initial U.S. Approval: 2012

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.

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 “0797” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate)104 mgVitamin B 6 (Pyridoxine HCI)    25    mg
Iron (Carbonyl iron)   29 mgFolic Acid      1    mg
Vitamin D 3 (Cholecalciferol) 400 |UDocusate Sodium   50    mg
Vitamin E (d|-alpha tocopheryl acetate)   30 |UDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)265    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 contraindictated in patients with a known hypersensitivity to any of the ingredients.

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 B 12 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 0178–0797–30

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

Please consult your health care provider with any dietary concerns.




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


CitraNatal Sample Carton
NDC 0178-0797-06

sample-carton-0178-0797-06

CitraNatal Label
NDC 0178-0797-05

CitraNatal-Label-0178-0797-05

CitraNatal Starter Pack

CitraNatal-StarterPack

CitraNatal Label
NDC 0178-0797-30

CitraNatal-Label-0178-0797-30
CITRANATAL HARMONY 2.1 
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:0178-0797
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION104 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON29 mg
Inactive Ingredients
Ingredient NameStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) 400 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 30 [iU]
PYRIDOXINE (UNII: KV2JZ1BI6Z) 25 mg
FOLIC ACID (UNII: 935E97BOY8) 1 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) 50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) 265 mg
Product Characteristics
Colorpurple (opaque) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code 0797
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0797-051 in 1 CARTON01/21/201303/21/2014
15 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0178-0797-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/21/201303/21/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/21/2013
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Accucaps Industries Limited248441727manufacture(0178-0797)

Revised: 5/2019
Document Id: 88dc0784-2854-b47f-e053-2a95a90ac51a
Set id: 00ecf076-d840-bee7-38d1-48bae1066bff
Version: 3
Effective Time: 20190514
 
Mission Pharmacal Company