Label: CARDIOTEK-RX- bioperine, folic acid, l-arginine hcl, vitamin b-12, vitamin b6 tablet, coated

  • NDC Code(s): 24839-333-30, 24839-333-99
  • Packager: SJ PHARMACEUTICALS, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 26, 2018

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  • DESCRIPTION:

    Cardiotek®-RX is a multi-B arginine supplement containing
    essential cofactors in reducing elevated homocysteine levels.

    DESCRIPTION:

    Each orange, football-shaped coated tablet contains:
    Bioperine® (Black Pepper Extract) ...................... 5 mg
    Folic Acid ............................................................ 2 mg
    L-Arginine HCl ................................................ 500 mg
    Cyanocobalamin (Vitamin B12) ...................... 500 mcg
    Pyridoxine (Vitamin B6) .................................... 50 mg
    Also contains the following inactive ingredients:
    croscarmellose sodium, dicalcium phosphate, FD&C yellow
    no. 6 aluminum lake, hydroxypropyl cellulose, hypromellose,
    magnesium stearate, microcrystalline cellulose, polydextrose,
    polyethylene glycol, stearic acid, titanium dioxide, triacetin.
    Cardiotek®-RX tablets are free of sugar, lactose and gluten.

    Bioperine® increases bioavailability of folic acid, Vitamin B6,
    and Vitamin B12, and has the following chemical structure:

    Bioperine

    Folic Acid is yellowish-orange crystal. The chemical name is
    N-[4[ [ (2-Amino-1, 4-dihydro-4-oxo-6-pteridinyl)methyl]
    amino]benzoyl]-L-glutamic acid. Its empirical formula is
    C19H19N7O6.
    The use of supplemental folic acid
    may be indicated in patients with
    increased requirements for this
    vitamin. Folic acid administration may
    reduce the risk of neural tube defects
    in the developing fetus. Folate as
    5-methyltetrahydrofolate and Vitamin
    B12 as methylcobalamin participate in
    the remethylation reaction of
    homocysteine to methionine.

    Folic Acid


    L-Arginine is a basic amino acid with
    the molecular formula C6H14N4O2 and
    with a molecular weight of 174.20. It
    has 3 pKs: pK1=2.18, pK2=9.09 and
    pK3=13.2. Therefore, it carries a
    positive charge at physiological pH.
    The stereoisomer of L-arginine,
    D-arginine, does not have any
    biological activity, as far as we know.
    L-Arginine is also known as
    2-amino-5- guanidinovaleric acid and
    (S)-2-amino-5- [(aminoiminomethyl)
    amino] pentanoic acid. Its one-letter
    abbreviation is R. It is also
    abbreviated as Arg. The terms
    L-arginine and arginine are frequently
    used interchangeably. The structural
    formula of L-arginine is as follows:

    L-Arginine
    L-Arginine shows promise as a
    nutritional adjunct in patients
    undergoing treatment for
    cardiovascular disease (including
    atherosclerosis, hypertension,
    hyperlipidemia and angina pectoris),
    some forms of male infertility and
    some kidney disorders and for wound
    healing in some circumstances.
    There is preliminary evidence that it
    could be helpful as a nutritional
    adjunct in some men undergoing
    treatment for erectile dysfunction and
    in some others being treated for
    migraine, liver disease and primary
    ciliary dyskinesia. There is conflicting
    but mostly negative evidence related
    to claims that it can improve exercise
    performance and promote lean
    muscle mass.
    Cyanocobalamin (Vitamin B12)
    appears as dark red crystals or
    crystalline red powder. The chemical
    name is 5,6-dimethylbenzimidazolyl
    cyanocobamide. Its empirical
    formula is C63H88CoN14O14P. The
    structural formula of
    Cyanocobalamin is as follows:

    Vitamin B12
    Pyridoxine (Vitamin B6) is a
    colorless or white crystal or a white
    crystalline powder. It is stable in air
    and is slowly affected by sunlight.
    The chemical name is 2-methly-3
    hydroxy-4, 5-bis (hydroxymethyl)
    pyridine. Pyridoxine’s empirical
    formula is C8H11NO3. A pyridine
    derivative, C18H11NO3, occurring
    especially in cereals, yeast, liver, and
    fish and serving as a coenzyme in
    amino acid synthesis.

    Vitamin B6

  • PRECAUTIONS:

    Folic acid in doses above 1 mg daily
    may obscure pernicious anemia in that hematologic
    remission can occur while neurological manifestations
    remain progressive. An oral dose of 100-250 mcg/day
    will maintain adequate serum Vitamin B12 levels in
    most patients with pernicious anemia, although some
    patients may require as much as 1,000 mcg/day. Those
    with renal or hepatic failure should exercise caution in
    the use of supplemental L-arginine. Proteins of the
    herpes simplex virus are rich in L-arginine, and there
    are a few reports (mainly anecdotal) of those taking
    supplemental L-arginine who ave had recurrences of oral
    herpes lesions. Although it is unlikely that those with a
    history of herpes simplex virus infection will have
    recurrences if they use L-arginine supplements, they
    should nevertheless be aware of this possibility.

  • DOSAGE AND ADMINISTRATION:

    Adult dosage 1 to 2
    tablets daily, or as prescribed by a physician or
    practitioner.
    Not recommended for use in pediatrics.

  • WARNING:

    Keep this and all medicine out of the reach of
    children.
    is a registered trademark of
    Sabinsa Corporation. Patent Numbers:
    6,849,645/5,972,382/5,744,161/5,536,506/6,054,585
    Rx only
    Distributed by:
    SJ Pharmaceuticals, LLC
    1212 Collier Road NW
    Atlanta, GA 30318
    Rev. 10/17 7102

  • PRINCIPAL DISPLAY PANEL

    NDC 24839-333-30
    CARDIOTEK®-RX TABLETS
    Multi-B and Arginine Supplement

    Each tablet contains:
    Bioperine® (Black Pepper Extract) .. 5 mg
    Folic Acid ...................................... 2 mg
    L-Arginine HCl .......................... 500 mg
    Vitamin B12 .............................. 500 mcg
    Vitamin B6 .................................. 50 mg

    SJ Pharmaceuticals, LLC

    Rx only CONTENTS: 30 Tablets

    DOSAGE AND ADMINISTRATION:
    Adult dosage 1 to 2 tablets daily, or as
    prescribed by a physician or practitioner.
    Not recommended for use in pediatrics.


    KEEP THIS AND ALL MEDICINE
    OUT OF THE REACH OF CHILDREN.
    Pharmacist: Dispense in a tight, lightresistant
    container as defined in the
    USP/NF with a child resistant closure.
    Store at room temperature 15°C to 30°C
    (59°F-86°F).
    BIOPERINE®
    is a registered trademark
    of Sabinsa Corporation.

    Patent Numbers: 6,849,645/5,972,382/
    5,744,161/5,536,506/6,054,585
    Distributed by:
    SJ Pharmaceuticals, LLC
    1212 Collier Road NW
    Atlanta, GA 30318
    Rev. 10/17

    PACKAGE LABEL

    LABEL INSERT

  • INGREDIENTS AND APPEARANCE
    CARDIOTEK-RX 
    bioperine, folic acid, l-arginine hcl, vitamin b-12, vitamin b6 tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:24839-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER5 mg  in 58 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID2 mg  in 58 mg
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE.5 mg  in 58 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN.5 mg  in 58 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE50 mg  in 58 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:24839-333-301740 mg in 1 BOTTLE
    2NHRIC:24839-333-9958 mg in 1 DOSE PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement05/01/2008
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    imprint
    scoring1
    size (solid drugs)8 mm
    Labeler - SJ PHARMACEUTICALS, LLC (845662720)
    Registrant - NEXGEN PHARMA (040488621)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXGEN PHARMA040488621manufacture(24839-333)