CitraNatal Harmony 3.0

Manufacturer
Mission Pharmacal Company
Effective date
2025-08-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 20:35:04

Label at a glance#

ProductCitraNatal Harmony 3.0
Active ingredientCALCIUM CITRATE, IRON, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, FOLIC ACID, DOCUSATE SODIUM, DOCONEXENT
Label structure10 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#

WARNING

BOXED WARNING SECTION

Accidental overdose of iron-containingproducts 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.

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 “0796” in white ink.

Each prenatal capsule contains:
Calcium (Calcium citrate)104 mgVitamin B 6(Pyridoxine HCl)    25    mg
Iron (Ferrous fumarate, carbonyl iron)   27 mgFolic Acid      1    mg
Vitamin D 3(Cholecalciferol) 400 IUDocusate Sodium   50    mg
Vitamin E (dl-alpha tocopheryl acetate)   30 IUDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)260    mg

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 contraindictated in patients with a known hypersensitivity to any of the ingredients.

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

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12is 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 0178-0796-30

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

Please consult your health care provider with any dietary concerns.




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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CitraNatal Label

NDC 0178-0796-30

LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0796-30EA - Each0178-0796ad2aded3-4cdc-415c-8382-18c7007b454d12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROLACTIVE INGREDIENTH4N855PNZ11
CALCIUM CITRATEACTIVE INGREDIENTMLM29U2X851
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JC1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA01
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
IRONACTIVE INGREDIENTE1UOL152H71
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6Z1
.ALPHA.-TOCOPHEROLACTIVE MOIETYH4N855PNZ11
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
DOCONEXENTACTIVE MOIETYZAD9OKH9JC1
DOCUSATEACTIVE MOIETYM7P27195AG1
FOLIC ACIDACTIVE MOIETY935E97BOY81
IRONACTIVE MOIETYE1UOL152H71
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
GELATININACTIVE INGREDIENT2G86QN327L1

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
0178-07960178-0796-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates

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
3c472b11-b612-f6d8-e063-6394a90a38e1445aeccb-7324-451e-8eac-43dc7b4922452025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 3c472b11-b612-f6d8-e063-6394a90a38e1
spl set id: 445aeccb-7324-451e-8eac-43dc7b492245

Reported adverse events (FAERS/openFDA)#

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