Label: CITRANATAL B-CALM- ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit

  • NDC Code(s): 0178-0832-30
  • Packager: Mission Pharmacal Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 8, 2024

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  • 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

    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

    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

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

  • BOXED WARNING (What is this?)

    WARNING

    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

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

  • PRECAUTION

    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

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

  • 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.

  • HOW SUPPLIED

    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

    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

    Label

  • INGREDIENTS AND APPEARANCE
    CITRANATAL B-CALM 
    ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0832
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0832-306 in 1 CARTON06/18/2012
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 BLISTER PACK 30 
    Part 26 BLISTER PACK 60 
    Part 1 of 2
    PRENATAL VITAMIN 
    ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS120 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON20 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) 174.3 mg
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 55 mg
    POVIDONE (UNII: FZ989GH94E) 30 mg
    HYPROMELLOSES (UNII: 3NXW29V3WO) 18.9 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) 17.5 mg
    MAGNESIUM SILICATE (UNII: 9B9691B2N9) 9 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 2.2 mg
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.25 mg
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 0832
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/18/2012
    Part 2 of 2
    VITAMIN B6 
    pyridoxine hydrochloride tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code B;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/18/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/18/2012
    Labeler - Mission Pharmacal Company (008117095)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutra-Med Packaging, Inc.022004902pack(0178-0832)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0832)
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