NICAPRIN- nicotinamide, folic acid, pyridoxine hydrochloride, cupric oxide, zinc oxide, and soliprin tablet 
Artesa Labs, LLC

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NICAPRINTM

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.

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

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)

Revised: 9/2016
Document Id: b57bbc99-7770-4cae-b955-966485bca08f
Set id: 52cc4bd5-427f-4a5e-8da0-a4cca3258899
Version: 1
Effective Time: 20160923
 
Artesa Labs, LLC