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

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 22, 2018

If you are a consumer or patient please visit this version.

  • 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.

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  • SPL UNCLASSIFIED SECTION

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

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  • DESCRIPTION

    CitraNatal B-Calm ® is a prescription prenatal multivitamin/mineral tablet with B 6, along with two vitamin B 6 tablets. 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 6 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) 120 mg
    Iron (Carbonyl iron, Ferrous gluconate) 20 mg
    Vitamin D 3 (Cholecalciferol) 400 IU
    Vitamin B 6 (Pyridoxine HCl) 25 mg
    Folic Acid 1 mg
    Each vitamin B 6 tablet contains:
    Vitamin B 6 (Pyridoxine HCl) 25 mg
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  • 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.

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  • CONTRAINDICATIONS

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

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  • WARNING

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

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  • 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.

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  • ADVERSE REACTIONS

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

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  • 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.

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  • HOW SUPPLIED

    Six child-resistant blister packs of 5 multivitamin/multimineral tablets and 10 vitamin B 6 tablets each - NDC 0178-0832-30.

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  • SPL UNCLASSIFIED SECTION

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

    50310 C01 Rev 008110

    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 © 2009 Mission Pharmacal Company.

    All rights reserved.

    Ferr-Ease™
    Dual-iron delivery

    Trademark of Mission Pharmacal Company
    U.S. Patent No. 6,521,247

    life's DHA™
    HEALTHY BRAIN, EYES, HEART

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

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

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  • PRINCIPAL DISPLAY PANEL - Blister Pack Carton

    Rx Only
    NDC 0178-0832-30

    The gentle option for
    additional B 6

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

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

    march of dimes®

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

    Mission®
    PHARMACAL

    CONTAINS
    Six 5-day Blister Packs

    citranatal-bcalm-carton
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  • INGREDIENTS AND APPEARANCE
    CITRANATAL B-CALM 
    ascorbic acid, calcium citrate, iron, cholecalciferol, pyridoxine hydrochloride, and folic acid kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0832
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0178-0832-30 6 in 1 CARTON 06/18/2012
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 6 BLISTER PACK 30 
    Part 2 6 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 Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS 120 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 20 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score no score
    Shape OVAL Size 19mm
    Flavor Imprint Code 0832
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/18/2012
    Part 2 of 2
    VITAMIN B6 
    pyridoxine hydrochloride tablet
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code B;6
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/18/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 06/18/2012
    Labeler - Mission Pharmacal Company (008117095)
    Establishment
    Name Address ID/FEI Business Operations
    Nutra-Med Packaging, Inc. 080274725 pack(0178-0832)
    Establishment
    Name Address ID/FEI Business Operations
    Mission Pharmacal Company 927726893 manufacture(0178-0832)
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