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CitraNatal Harmony 3.0

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

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.

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.

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 3.0 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 “0796” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate) 104 mg Vitamin B6 (Pyridoxine HCl)    25    mg
Iron (Ferrous fumarate, 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 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 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 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 3.0 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 3.0 Supplied

Bottles of 30 capsules each - NDC 0178-0796-30

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 0178-0796-06

CitraNatal Label
NDC 0178-0796-05

CitraNatal Starter Pack

CitraNatal Label
NDC 0178-0796-30

CitraNatal Harmony 3.0 
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:0178-0796
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE ANHYDROUS 104 mg
IRON (IRON) IRON 27 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 260 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
Product Characteristics
Color PURPLE (opaque) Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 0796
Contains         
Packaging
# Item Code Package Description
1 NDC:0178-0796-05 1 BOTTLE in 1 CARTON
1 5 CAPSULE, GELATIN COATED in 1 BOTTLE
2 NDC:0178-0796-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/21/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 MANUFACTURE(0178-0796)
Revised: 03/2014
 
Mission Pharmacal Company
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