CitraNatal B-Calm ® Rx Prenatal Vitamin and two 25 mg each B 6 tablets

Manufacturer
Mission Pharmacal Company | Nutra-Med Packaging, Inc.
Effective date
2024-01-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:15:30

Label at a glance#

ProductCITRANATAL B-CALM
Active ingredientPYRIDOXINE HYDROCHLORIDE, FOLIC ACID, ASCORBIC ACID, CALCIUM CITRATE, IRON, CHOLECALCIFEROL
Label structure12 sections

Boxed warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Dosage and administration

One tablet every eight hours, beginning with "Tablet 1", or as directed by a physician. Store at controlled room temperature. NOTICE: Contact with moisture can discolor or erode tablets.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B 6which may act as an antiemetic.

DESCRIPTION

DESCRIPTION SECTION

CitraNatal B-Calm ®is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6tablets. The prenatal tablet contains Ferr-Ease ®, a patented dualiron delivery comprising both a quick release and slow release iron. The prenatal tablet is white, coated, modified oval, and is debossed with "0832" on one side and is blank on the other. The B 625 mg tablets are white to off-white, uncoated, round, and are debossed with "B" on one side and "6" on the other.

Each prenatal tablet contains:
Vitamin C (Ascorbic acid)120 mg
Calcium (Calcium citrate)120 mg
Iron (Carbonyl iron, Ferrous gluconate)20 mg
Vitamin D 3(Cholecalciferol) 400 IU
Vitamin B 6(Pyridoxine HCl) 25 mg
Folic Acid1 mg
Each vitamin B 6tablet contains:
Vitamin B 6(Pyridoxine HCl) 25 mg

INDICATIONS

INDICATIONS & USAGE SECTION

CitraNatal B-Calm ®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. CitraNatal B-Calm ®may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.

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-containingproducts is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

WARNING

WARNINGS SECTION

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

PRECAUTION

PRECAUTIONS SECTION

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

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 every eight hours, beginning with "Tablet 1", or as directed by a physician.

STORAGE AND HANDLING SECTION

Store at controlled room temperature.

NOTICE:Contact with moisture can discolor or erode tablets.

HOW SUPPLIED

HOW SUPPLIED SECTION

Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B 6tablets each - NDC0178-0832-30.

SPL UNCLASSIFIED SECTION

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

50310 C01 Rev 0820

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

www.missionpharmacal.com

Copyright © 2020 Mission Pharmacal Company.

All rights reserved.

PRINCIPAL DISPLAY PANEL - Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC0178-0832-30

The gentle option for additional B 6

CitraNatalB-Calm®

Rx Prenatal Vitamin and two 25 mg each Vitamin B 6tablets

A prescription prenatal supplement with 1 mg of folic acid and a high level of vitamin B 6which may act as an antiemetic.

CONTAINS

Six 5-day Blister Packs

LabelLabel

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0832-30EA - Each0178-0832aff0311e-6e77-4e92-869d-bd54e5d13c2f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Ascorbic acidACTIVE INGREDIENTPQ6CK8PD0R1
Calcium citrateACTIVE INGREDIENTMLM29U2X851
CholecalciferolACTIVE INGREDIENT1C6V77QF411
Folic AcidACTIVE INGREDIENT935E97BOY81
IronACTIVE INGREDIENTE1UOL152H71
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
Ascorbic acidACTIVE MOIETYPQ6CK8PD0R1
CalciumACTIVE MOIETYSY7Q814VUP1
CholecalciferolACTIVE MOIETY1C6V77QF411
Folic AcidACTIVE MOIETY935E97BOY81
IronACTIVE MOIETYE1UOL152H71
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIH1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
IRON PENTACARBONYLINACTIVE INGREDIENT6WQ62TAQ6Z1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N91
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0178-08320178-0832-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 3 · 148 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION/ DROPS / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9WAFER / ORAL22 mgExact identifier — unii candidate
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9PASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSHAMPOO / TOPICAL3 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9TABLET, COATED / ORAL29.03 mgExact identifier — unii candidate
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERDIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHSUSPENSION / ORAL255 mgExact identifier — unii candidate
14 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERDIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHTABLET, ORALLY DISINTEGRATING / ORAL222 mgExact identifier — unii candidate
14 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYSTEM / TOPICAL54 mgExact identifier — unii candidate
27 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERDIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERDIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM SILICATEMAGNESIUM SILICATE9B9691B2N9SOAP / TOPICAL0.33 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED PELLETS / ORAL3.32 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERDIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHGRANULE / ORAL229 mgExact identifier — unii candidate
14 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii candidate
27 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii candidate
30 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
3c473c84-16bb-b3b2-e063-6294a90a2e36a524c0ff-4893-4df0-aaca-7f690b2bbb132025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: a524c0ff-4893-4df0-aaca-7f690b2bbb13

Reported adverse events (FAERS/openFDA)#

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