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CitraNatal Medley

Package insert / prescribing information
Generic name: prenatal/postnatal multi-vitamin/mineral
Dosage form: capsule

Medically reviewed by Drugs.com. Last updated on Feb 1, 2021.

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.

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.

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.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

CitraNatal Medley™ is a prescription prenatal/postnatal multi-vitamin/mineral soft gel with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and DHA, an essential fatty acid. The prenatal vitamin is an oval, purple, opaque soft gel containing a greenish-grey liquid to semi-solid fill. The prenatal soft gel is printed “896” in white ink.

CitraNatal Medley is a multi-vitamin/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.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

One prenatal soft gel daily or as directed by a physician.

Bottles of 30 soft gels each - NDC 00178-0896-30.

CitraNatal Medley
calcium citrate, iron pentacarbonyl, ferrous fumarate, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, and doconexent capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0896
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 2 mg
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE ANHYDROUS 62 mg
IRON (IRON) IRON 27 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 200 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 15 [iU]
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 12.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 200 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
GELATIN
LECITHIN, SUNFLOWER
TITANIUM DIOXIDE
BUTYLATED HYDROXYTOLUENE
FD&C BLUE NO. 1
ETHYL VANILLIN
D&C RED NO. 33
Product Characteristics
Color purple (opaque) Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code 596
Contains
Packaging
# Item Code Package Description
1 NDC:0178-0896-30 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 03/20/2018
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
Name Address ID/FEI Operations
Catalent Ontario Limited 243944050 manufacture(0178-0896)
Mission Pharmacal Company

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