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CitraNatal Essence

Generic name: ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent
Dosage form: capsule

Medically reviewed by Drugs.com. Last updated on Jul 1, 2020.

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.

CitraNatal Essence Description

CitraNatal Essence™ is a prescription prenatal/postnatal multi-vitamin/ mineral tablet with Ferr-Ease®, a 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 white, coated, oval multi-vitamin/mineral tablet. The tablet is debossed “0864” on one side and is blank on the other. The essential fatty acid DHA soft gel is oblong, transparent, and caramel colored.

INDICATIONS

CitraNatal Essence TM is a multivitamin/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

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 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.

CitraNatal Essence Dosage and Administration

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

STORAGE

Store at 20–25°C (68–77°F)

NOTICE

Contact with moisture can discolor or erode the tablet.

To report a serious adverse event or obtain product information, call (210) 696-8400.

51065R0420

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

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.

Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0864-30

Retail Carton

CitraNatal Essence
ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0178-0864
Packaging
# Item Code Package Description
1 NDC:0178-0864-30 30 BLISTER PACK in 1 CARTON
1 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1
Part 2 1
Part 1 of 2
PRENATAL VITAMIN
ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium tablet, coated
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
IRON (IRON) IRON 35 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
IODINE (IODINE) IODINE 150 ug
ZINC (ZINC) ZINC 25 mg
COPPER (COPPER) COPPER 2 mg
THIAMINE (THIAMINE ION) THIAMINE 3 mg
CALCIUM CITRATE (CALCIUM CATION) CALCIUM CITRATE ANHYDROUS 140 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE K30
CROSCARMELLOSE SODIUM
TITANIUM DIOXIDE
MAGNESIUM SILICATE
MAGNESIUM STEARATE
SHELLAC
VANILLIN
Product Characteristics
Color white Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 0864
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/07/2020
Part 2 of 2
DHA
doconexent and icosapent capsule
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 300 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.75 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
SUNFLOWER OIL
GLYCERIN
LECITHIN, SUNFLOWER
ROSEMARY
TOCOPHEROL
ASCORBYL PALMITATE
Product Characteristics
Color orange (caramel color) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/07/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/07/2020
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
Name Address ID/FEI Operations
Mission Pharmacal Company 927726893 manufacture(0178-0864)
Mission Pharmacal Company

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