CITRANATAL MEDLEY- calcium citrate, iron pentacarbonyl, ferrous fumarate, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, and doconexent capsule, gelatin coated

CitraNatal Medley by

Drug Labeling and Warnings

CitraNatal Medley by is a Prescription medication manufactured, distributed, or labeled by Mission Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOXED WARNING

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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.

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.

DESCRIPTION

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.

INDICATIONS & USAGE

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.

CONTRAINDICATIONS

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

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.

DOSAGE & ADMINISTRATION

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

HOW SUPPLIED

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 0178-0896
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	2 mg
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CITRATE ANHYDROUS	62 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	27 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	200 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	15 [iU]
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	200 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ETHYL VANILLIN (UNII: YC9ST449YJ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	purple (opaque)	Score	no score
Shape	CAPSULE	Size	25mm
Flavor		Imprint Code	596
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0896-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/20/2018

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	Business Operations
Catalent Ontario Limited		243944050	manufacture(0178-0896)