CitraNatal Bloom DHA Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

Manufacturer
Mission Pharmacal Company
Effective date
2020-04-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:32:38

Label at a glance#

ProductCitraNatal Bloom DHA
Active ingredientASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, FERROUS GLUCONATE, IRON PENTACARBONYL, DOCUSATE SODIUM, CRYPTHECODINIUM COHNII DHA OIL
Label structure11 sections

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.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Retail Carton

Retail CartonRetail Carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0816-30CitraNatal Bloom DHA30 in 1 CARTONKIT303
0178-0816-30CitraNatal Bloom DHA1 in 1 BLISTER PACKKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0816CITRANATAL BLOOM DHA (IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID, DOCUSATE SODIUM AND DHA) KIT [MISSION PHARMACAL COMPANY]3Legacy NDC, 2 package rows20200407_63004034-123d-c9c8-e053-2991aa0a359a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0816-30EA - Each0178-081656287b6f-48d4-42ff-864b-e171dfdaae8d12018-02-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0178-08160178-0816-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a2a1c709-8dd2-44c5-e053-2995a90a149063004034-123d-c9c8-e053-2991aa0a359a2020-04-06Warnings, Adverse reactionsExact identifier
spl id: a2a1c709-8dd2-44c5-e053-2995a90a1490
spl set id: 63004034-123d-c9c8-e053-2991aa0a359a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.