CitraNatal ® Harmony ™ Rx Prenatal Vitamin Gel Cap

Manufacturer
MISSION PHARMACAL COMPANY | Accucaps Industries Ltd.
Effective date
2010-05-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:11:48

Label at a glance#

ProductCitraNatal Harmony
Active ingredientCalcium citrate, Iron pentacarbonyl, Cholecalciferol, Alpha-tocopherol, DL-, Pyridoxine hydrochloride, Folic Acid, Docusate Sodium, Doconexent
Label structure12 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 capsule daily or as directed by a physician. Store at controlled room temperature. NOTICE: Contact with moisture can discolor or erode the capsule.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

CitraNatal® Harmony™ is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed "0812" in white ink.

Each prenatal capsule contains:

Calcium (Calcium citrate)100 mgVitamin B6 (Pyridoxine HCl)25 mg
Iron (Carbonyl iron)27 mgFolic Acid1 mg
Vitamin D3 (Cholecalciferol)400 IUDocusate Sodium50 mg
Vitamin E (dl-alpha tocopheryl acetate)30 IUDocosahexaenoic Acid (DHA)250 mg

DHA is contained in the oil derived from microalgae.

INDICATIONS

INDICATIONS & USAGE SECTION

CitraNatal® Harmony™ 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 B12 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.

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One capsule daily or as directed by a physician.

Store at controlled room temperature.

NOTICE: Contact with moisture can discolor or erode the capsule.

HOW SUPPLIED

HOW SUPPLIED SECTION

Bottles of 30 capsules each - NDC 0178-0812-30.

SPL UNCLASSIFIED SECTION

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

life'sDHA™

Trademark of Martek Biosciences Corporation
U.S. Patent No. 5,407,957
U.S. Patent No. 5,492,938

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

www.missionpharmacal.com

Copyright © 2009 Mission Pharmacal Company. All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The one-pill solution
for gentle prenatal nutrition

Rx Only
NDC
0178-0812-05

CitraNatal® Harmony™
Rx Prenatal Vitamin Gel Cap

  • Convenient, one-dose prenatal nutrition
    in a vanilla-scented gel cap
     
  • Gentle calcium citrate and carbonyl iron,
    plus a stool softener and natural,
    plant-based DHA

life'sDHA ™
HEALTHY BRAIN, EYES, HEART

5-DAY STARTER PACK
In Child-Resistant Packaging
Sample-Not For Sale

Contains
Stool Softener

Mission®
PHARMACAL

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0812-302020-01-31C16284748780-19d75b9cf-f27e-f424-e053-dadaa90a57ceCitraNatal ® Harmony ™ Rx Prenatal Vitamin Gel Cap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0812-30CitraNatal Harmony30 in 1 BOTTLECAPSULE, GELATIN COATED301
0178-0812-30CitraNatal Harmony1 in 1 CARTONCAPSULE, GELATIN COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0812CITRANATAL HARMONY (CALCIUM CITRATE, IRON PENTACARBONYL, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, AND DOCONEXENT) CAPSULE, GELATIN COATED [MISSION PHARMACAL COMPANY]1Legacy NDC, 2 package rows20110428_76ad10bd-3a53-4df5-b1c4-c98dbebe2fed.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Alpha-tocopherol, DL-ACTIVE INGREDIENT7QWA1RIO011
Calcium citrateACTIVE INGREDIENTMLM29U2X851
CholecalciferolACTIVE INGREDIENT1C6V77QF411
DoconexentACTIVE INGREDIENTZAD9OKH9JC1
Docusate SodiumACTIVE INGREDIENTF05Q2T2JA01
Folic AcidACTIVE INGREDIENT935E97BOY81
Iron pentacarbonylACTIVE INGREDIENT6WQ62TAQ6Z1
Pyridoxine hydrochlorideACTIVE INGREDIENT68Y4CF58BV1
Alpha-tocopherol, DL-ACTIVE MOIETY7QWA1RIO011
CalciumACTIVE MOIETYSY7Q814VUP1
CholecalciferolACTIVE MOIETY1C6V77QF411
DoconexentACTIVE MOIETYZAD9OKH9JC1
DocusateACTIVE MOIETYM7P27195AG1
Folic AcidACTIVE MOIETY935E97BOY81
IronACTIVE MOIETYE1UOL152H71
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0178-08120178-0812-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
ffeb77e7-167b-4049-aa46-81ec06f218d176ad10bd-3a53-4df5-b1c4-c98dbebe2fed2010-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: ffeb77e7-167b-4049-aa46-81ec06f218d1
spl set id: 76ad10bd-3a53-4df5-b1c4-c98dbebe2fed

Reported adverse events (FAERS/openFDA)#

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