Label: NICAPRIN- nicotinamide, folic acid, pyridoxine hydrochloride, cupric oxide, zinc oxide, and soliprin tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated September 23, 2016

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  • HEALTH CLAIM

    Rx Only Dietary Supplement

  • DESCRIPTION:

    This product is a prescription dietary supplement for oral administration, specifically formulated for the dietary management of patients with unique nutritional needs who require increased levels of one or more of the ingredients in this product. Each tan colored caplet-shaped tablet is debossed with “203” on one side and plain on the other.

  • INGREDIENTS:

    Each tablet of NicaprinTM contains:

     Niacin (nicotinamide) 250 mg
     Folic Acid 500 mcg
     Vitamin B6 (pyridoxine HCl) 4.5 mg
     Copper (cupric oxide) 1.4 mg
     Zinc (zinc oxide) 9 mg
     Soliprin (scutellaria baicalensis (root) & acacia catechu (heartwood)) 125 mg

    OTHER INGREDIENTS:

    Iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium bicarbonate, starch, silica, talc, and titanium dioxide.

  • INDICATIONS AND USAGE:

    This product is indicated for patients who are deficient in, or at risk of deficiency in, one or more of the components of this product.

  • CONTRAINDICATIONS

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

  • WARNINGS AND PRECAUTIONS:

    This product should be administered with caution in patients with a history of liver disease, jaundice or diabetes mellitus. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs and/or supplements should be considered. Folic acid above 1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive. Abnormal liver functions tests have been reported in persons taking daily doses of 500 mg or more of niacinamide.

    KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

  • PREGNANCY & NURSING MOTHERS:

    This product is not indicated for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. Physicians and medical practitioners should administer this product with caution to patients who are pregnant, lactating and/or taking medication.

  • ADVERSE REACTIONS:

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

  • DOSAGE AND ADMINISTRATION:

    Usual adult dose is 1 to 2 tablets daily, or as directed by a physician.

  • HOW SUPPLIED:

    This product is supplied in the following size(s):
    60 count bottles, NDC 57893-203-60

    Store between 15°C and 30°C (between 59°F and 86°F). Tamper evident by foil seal under cap.

  • HEALTH CLAIM

    Manufactured for:
    Artesa Labs, LLC
    137585 Research Blvd.
    Suite 125
    Austin, TX 78750
    v1 Rev. 05/16 826146

  • PRINCIPAL DISPLAY PANEL - 60 TABLET BOTTLE LABEL

    NDC 57893-203-60

    Rx Only

    NICAPRINTM

    Dietary Supplement

    60 Tablets

    Artesa Labs

    label

  • INGREDIENTS AND APPEARANCE
    NICAPRIN 
    nicotinamide, folic acid, pyridoxine hydrochloride, cupric oxide, zinc oxide, and soliprin tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:57893-203
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN250 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID500 ug
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1.4 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE4.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SCUTELLARIA BARBATA WHOLE (UNII: DPR4R122E7)  
    ACACIA CATECHU WOOD (UNII: CHL342Y4LA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:57893-203-6060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement09/21/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)14 mm
    scoring1
    imprint
    Labeler - Artesa Labs, LLC (078786339)
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