CITRANATAL BLOOM DHA- iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kit

CitraNatal Bloom DHA by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

CitraNatal Bloom™ DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other. The essential fatty acid DHA soft gel is oblong, light brown and contains a yellow to orange fill.

Each prenatal tablet contains:

Iron (Carbonyl iron, ferrous gluconate)...........................90 mg

Folic Acid .........................................................................1 mg

Vitamin B12 (Cyanocobalamin) ...................................12 mcg

Vitamin C (Ascorbic acid).............................................120 mg

Docusate sodium ..........................................................50 mg

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

CitraNatal Bloom DHA 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.

WARNINGS AND PRECAUTIONS

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.

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.

CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Please consult your health care provider with any dietary concerns.

ADVERSE REACTIONS

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

DOSAGE & ADMINISTRATION

One tablet and one soft gel daily or as directed by a physician.

STORAGE AND HANDLING

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

Six child-resistant blister packs of 5 tablets and 5 soft gels each – NDC: 0178-00816-30.

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

51080R0717

MISSION ® PHARMACAL

DHA capsules manufactured for:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Prenatal tablets manufactured by:

MISSION PHARMACAL COMPANY

San Antonio, TX USA 78230 1355

Copyright © 2017 Mission Pharmacal Company.

All rights reserved.

www.missionpharmacal.com

Ferr-Ease ®

Dual-iron delivery

Trademark of Mission Pharmacal Company

U.S. Patent No. 6,521,247

life's DHA ®

life’sDHA is a trademark of DSM.

U.S. Patent No. 7,579,174

U.S. Patent No. 7,732,170

U.S. Patent No. 5,518,918

*March of Dimes does not endorse

specific products or brands.

March of Dimes is a registered trademark

of the March of Dimes Foundation.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC: 0178-0816-30

PRINCIPAL DISPLAY PANEL

Retail Carton

INGREDIENTS AND APPEARANCE

CITRANATAL BLOOM DHA 
iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0178-0816

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0816-30	30 in 1 CARTON	01/18/2018
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		1

Part 1 of 2

PRENATAL 
iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	1.5 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	88.5 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

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

Product Characteristics
Color	green (Coated Tablet)	Score	score with uneven pieces
Shape	RECTANGLE (Modified Rectangle)	Size	9mm
Flavor		Imprint Code	CB;blank
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/22/2018

Part 2 of 2

DHA 
dha capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CRYPTHECODINIUM COHNII DHA OIL (UNII: 8ZJ335A17J) (CRYPTHECODINIUM COHNII DHA OIL - UNII:8ZJ335A17J)	CRYPTHECODINIUM COHNII DHA OIL	300 mg  in 300 mg

Inactive Ingredients
Ingredient Name	Strength
ICOSAPENT (UNII: AAN7QOV9EA)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	brown (Soft gelatin capsule)	Score	no score
Shape	CAPSULE (Soft gelatin capsule)	Size	23mm
Flavor		Imprint Code	none
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		01/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/18/2018

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (922772689)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	manufacture(0178-0816)