CitraNatal Essence TM Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

Manufacturer
Mission Pharmacal Company
Effective date
2020-07-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:33:06

Label at a glance#

ProductCitraNatal Essence
Active ingredientASCORBIC ACID, IRON, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, IODINE, ZINC, COPPER, THIAMINE, CALCIUM CITRATE, DOCONEXENT, ICOSAPENT
Label structure13 sections

Boxed 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.

Dosage and administration

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

Storage and handling

Store at 20–25°C (68–77°F) Contact with moisture can discolor or erode the tablet.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

BOXED WARNING SECTION

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

WARNINGS SECTION

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

WARNINGS SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

PRECAUTIONS

PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

STORAGE

STORAGE AND HANDLING SECTION

Store at 20–25°C (68–77°F)

NOTICE

SPL UNCLASSIFIED SECTION

Contact with moisture can discolor or erode the tablet.

SPL UNCLASSIFIED SECTION

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

Copyright © 2020 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.

HOW SUPPLIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Retail Carton PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1535150docosaenoic acid 300 MG / eicosapentaenoic acid 0.75 MG Oral CapsulePSN1
1535150docosaenoic acid 300 MG / eicosapentaenoic acid 0.75 MG Oral CapsuleSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
COPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
f6766515-27b8-72de-2010-167151236aceProduct name720251021
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0864-302022-01-28C16284748780-1d6a99b39-f77d-a426-e053-dadaa90af4c2CitraNatal Essence TM Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0864-30CitraNatal Essence30 in 1 CARTONKIT301
0178-0864-30CitraNatal Essence1 in 1 BLISTER PACKKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0864CITRANATAL 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 [MISSION PHARMACAL COMPANY]1Legacy NDC, 2 package rows20200710_a9dc5d08-065e-7e82-e053-2995a90a59f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0864-30EA - Each0178-08644854e3f6-3882-4320-b1e3-cd3ee0bc99cd12020-08-06

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0178-08640178-0864-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
a9dc5d08-065f-7e82-e053-2995a90a59f2a9dc5d08-065e-7e82-e053-2995a90a59f22020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: a9dc5d08-065f-7e82-e053-2995a90a59f2
spl set id: a9dc5d08-065e-7e82-e053-2995a90a59f2

Reported adverse events (FAERS/openFDA)#

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