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

Warning:Accidental overdose of iron-containingproducts 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 TMis 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.

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.

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 12is 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.

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 — ( NDC0178-0813-30).

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

MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355

CitraNatal Bloom Label

Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0178-0813-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2017	06/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		08/01/2017	06/01/2024

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

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

Revised: 1/2024

Document Id: 0a0ce624-1a05-85f4-e063-6294a90ac29a

Set id: 2c9fd33d-4b38-42be-ad36-b1521ded47e1

Version: 13

Effective Time: 20240105

Mission Pharmacal Company