ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]

ZINGIBER (PYRIDOXINE, FOLIC ACID, CALCIUM, AND GINGER TABLET) TABLET [PRUGEN, INC. PHARMACEUTICALS]
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NDC 42546-300-60
Set ID 209da0f4-93d4-4690-9f07-7829334ce012
Category HUMAN PRESCRIPTION DRUG LABEL
Packager PruGen, Inc. Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number
  • WARNINGS AND PRECAUTIONS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid especially in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

    Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.

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  • DESCRIPTION

    Each pink tablet contains:

    Vitamin B6 (pyridoxine hydrochloride, USP) 40 mg

    Folic Acid, USP 1.2 mg

    Calcium (as dicalcium phosphate and tricalcium phosphate) 124.1 mg

    Ginger (zingiber officinale) root powder extract 100 mg

    Other ingredients: microcrystalline cellulose, maltodextrin, stearic acid, croscarmellose sodium, corn starch, magnesium stearate, silicon dioxide, talc, hypromellose, hydroxypropyl cellulose, polydextrose, titanium dioxide, medium chain triglycerides, FD&C Red #40.

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  • DOSAGE & ADMINISTRATION

    One or two tablets daily, in divided doses, or as directed by a physician.

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  • HOW SUPPLIED

    Store between 15-30°C (59-86°F). Protect from light and moisture.

    Keep out of the reach of children.

    DO NOT CHEW.

    Manufactured for:

    PruGen, Inc. Pharmaceuticals

    8714 E Vista Bonita Dr

    Scottsdale, AZ 85255

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  • PRINCIPAL DISPLAY PANEL

    NDC 42546-300-60

    Zingiber Tablets

    Rx prenatal vitamin with B vitamins and ginger

    Rx Only

    60 tablets

    label

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  • INGREDIENTS AND APPEARANCE
    ZINGIBER 
    pyridoxine, folic acid, calcium, and ginger tablet tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-300
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 40 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.2 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM 124.1 mg
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color pink Score no score
    Shape OVAL Size 24mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42546-300-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/01/2013
    Labeler - PruGen, Inc. Pharmaceuticals (929922750)
    Establishment
    Name Address ID/FEI Business Operations
    NuLab, Inc 102098324 manufacture(42546-300)
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