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







Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

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

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.

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.

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.

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

One tablet and one soft gel 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.

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

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.

CitraNatal Bloom DHA blisterSix child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0816-30

Retail Carton

Retail Carton

CITRANATAL BLOOM DHA 
iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0816
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0816-3030 in 1 CARTON01/18/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 1 of 2
PRENATAL 
iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION1.5 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION88.5 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (Coated Tablet) Scorescore with uneven pieces
ShapeRECTANGLE (Modified Rectangle) Size9mm
FlavorImprint Code CB;blank
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/22/2018
Part 2 of 2
DHA 
dha capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CRYPTHECODINIUM COHNII DHA OIL (UNII: 8ZJ335A17J) (CRYPTHECODINIUM COHNII DHA OIL - UNII:8ZJ335A17J) CRYPTHECODINIUM COHNII DHA OIL300 mg  in 300 mg
Inactive Ingredients
Ingredient NameStrength
ICOSAPENT (UNII: AAN7QOV9EA)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ROSEMARY (UNII: IJ67X351P9)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
Colorbrown (Soft gelatin capsule) Scoreno score
ShapeCAPSULE (Soft gelatin capsule) Size23mm
FlavorImprint Code none
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT01/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/18/2018
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (922772689)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893manufacture(0178-0816)

Revised: 4/2020
Document Id: a2a1c709-8dd2-44c5-e053-2995a90a1490
Set id: 63004034-123d-c9c8-e053-2991aa0a359a
Version: 3
Effective Time: 20200406
 
Mission Pharmacal Company