CITRANATAL BLOOM- iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, film coated

CitraNatal Bloom by

Drug Labeling and Warnings

CitraNatal Bloom 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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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 Bloom TM is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease ®, a patented dual-iorn delivery comprising both a quick release and slow release iron. CitraNatal Bloom is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other.

ACTIVE INGREDIENT

Iron (Carbonyl iron, ferrous gluconate)	90	mg
Folic Acid	1	mg
Vitamin B 12 (Cyanocobalamin)	12	mcg
Vitamin C (Ascorbic acid)	120	mg
Docusate sodium	50	mg

Inactive Ingredients:

Povidone, croscarmellose sodium, acrylic resin, color added, magnesium stearate, FD&C Yellow No. 5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin A palmitate, ethyl vanillin.

CLINICAL PHARMACOLOGY

INDICATIONS

CitraNatal Bloom 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.

WARNING:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemia 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.

DRUG INTERACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE:

Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED:

Bottles of 30 tablets each — ( NDC 0178-0813-30).

SPL UNCLASSIFIED SECTION

To report a serious adverse event or obtain product information, call (800) 298-1087.

MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355

PRINCIPAL DISPLAY PANEL

CitraNatal Bloom 90 Label

INGREDIENTS AND APPEARANCE

CITRANATAL BLOOM 
iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0178-0813
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	138 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	88.5 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	55 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	13.2 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1.4 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	16.8 ug

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ETHYL VANILLIN (UNII: YC9ST449YJ)

Product Characteristics
Color	green	Score	no score
Shape	RECTANGLE (modified rectangle)	Size	9mm
Flavor		Imprint Code	CB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0813-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2017

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	manufacture(0178-0813)