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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 3, 2010

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  • SPL UNCLASSIFIED SECTION

    A prescription prenatal supplement with 1 mg folic acid and a high level of vitamin B6 which may act as an antiemetic.

  • DESCRIPTION

    CitraNatal® B-Calm™ is a prescription prenatal multivitamin/mineral tablet with a high level of B6, along with two vitamin B6 tablets. The prenatal tablet is white, coated, modified oval, and is debossed with "0866" on one side and is blank on the other. The B6 25 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)125 mg
    Iron (Carbonyl iron)20 mg
    Vitamin D3 (Cholecalciferol)400 IU
    Vitamin B6 (Pyridoxine HCl)25 mg
    Folic Acid1 mg

    Each vitamin B6 tablet contains:

    Vitamin B6 (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-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.

  • WARNING

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is 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 B6 tablets each - NDC 0178-0866-30.

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

  • SPL UNCLASSIFIED SECTION

    50307 C01 REV 010090

    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

    www.missionpharmacal.com
    Copyright © 2009 Mission Pharmacal Company.
    All rights reserved.

    *March of Dimes does not endorse specific products or brands. March of dimes is a registered trademark of the March of Dimes Foundation.

  • PRINCIPAL DISPLAY PANEL

    Rx Only
    NDC 0178-0866-30

    The gentle option for
    additional B6

    CitraNatal®B-Calm
    Rx Prenatal Vitamin with two 25 mg each Vitamin B6 tablets

    A prescription
    prenatal supplement
    with 1 mg of folic
    acid and a high level
    of vitamin B6 which
    may act as an
    antiemetic.

    march of dimes®

    Mission Pharmacal is a proud
    supporter of the March of Dimes.®

    CONTAINS
    Six 5-day Blister Packs

    Mission®
    PHARMACAL

    Chemical Structure
  • INGREDIENTS AND APPEARANCE
    CITRANATAL  B-CALM
    ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0866
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0866-305 in 1 CARTON
    11 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 5 
    Part 2 10 
    Part 1 of 2
    PRENATAL VITAMIN 
    ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, pyridoxine hydrochloride, folic acid tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid120 mg
    calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP) calcium citrate125 mg
    Iron Pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron Pentacarbonyl - UNII:6WQ62TAQ6Z) Iron Pentacarbonyl20 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
    folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8) folic acid1 mg
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Povidone (UNII: FZ989GH94E)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Magnesium Silicate (UNII: 9B9691B2N9)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVAL (modified) Size19mm
    FlavorImprint Code 0866
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/10/2010
    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
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Povidone (UNII: FZ989GH94E)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITE (off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code B;6
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/10/2010
    Labeler - Mission Pharmacal Company (008117095)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutra-Med Packaging Inc.022004902PACK
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