Label: NITRIVIA- niacin, folate, calcium, l-arginine, l-ornithine, beet, gotu kola, carrot, celery extract capsule
- NHRIC Code(s): 69499-354-60
- Packager: Solubiomix, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated August 24, 2023
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STATEMENT OF IDENTITY
NITRIVIA Dietary Supplemement for Nitric Oxide Health
Dispensed by Prescription‡
Serving Size: 1 Capsule Servings per container: 30 Amount Per Serving: %DV
Niacin (from no-flush inositol hexanicotinate)
Folate (from 1,000 mcg folic acid) 1665 mcg DFE 416% Calcium (as calcium posphate) 250 mg 5% L-Arginine 250 mg * L-Ornithine 250 mg * Organic Fermented Beet (root) 250 mg * Gotu Kola (Centella asiatica whole herb) 40 mg * Carrot (root) 40 mg * Celery extract (seed) 20 mg * *Daily Values (DV) not established
OTHER INGEDIENTS: Capsule (gelatin), calcium stearate, silica.
NITRIVIA capsules are an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nitric oxide and nutritional status in patients where advanced folate supplementation is required, and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.
NITRIVIA is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are “Generally Recognized as Safe” (GRAS) for their intended use.
PRECAUTION Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is
deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. NITRIVIA Capsules should only be used under the direction and supervision of a licensed medical practitioner.‡
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, call a doctor or poison control center immediately.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling 1-844-551-9911 or the FDA by calling 1-800-FDA-1088.
HOW SUPPLIED HEALTH CLAIM
NITRIVIA, Nitric Oxide Health
Each bottles contains 60 Capsules (white) 69499-354-60#
NITRIVIA Capsules are available as white, oblong capsules without and imprint and are available in 60-count bottles (69499-354-60#).
This product is not an Orange Book product.
Manufactured in USA for:
Madisonville, LA 70447
# Solubiomix does not represent these product codesto be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
‡ This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription.
†This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
1. Federal Register Notice of August 2, 1973 (38 FR 20750)
2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
3. Federal Register Notice of March 5, 1996 (61 FR 8760)
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
niacin, folate, calcium, l-arginine, l-ornithine, beet, gotu kola, carrot, celery extract capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69499-354 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INOSITOL NIACINATE (UNII: A99MK953KZ) (INOSITOL NIACINATE - UNII:A99MK953KZ) INOSITOL NIACINATE 100 mg CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 60 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE 250 mg ORNITHINE (UNII: E524N2IXA3) (ORNITHINE - UNII:E524N2IXA3) ORNITHINE 250 mg BEET (UNII: N487KM8COK) (BEET - UNII:N487KM8COK) BEET 250 mg CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 40 mg CARROT (UNII: L56Z1JK48B) (CARROT - UNII:L56Z1JK48B) CARROT 40 mg CELERY SEED (UNII: 1G1EAA320L) (CELERY SEED - UNII:1G1EAA320L) CELERY SEED 20 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) CALCIUM STEARATE (UNII: 776XM7047L) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) CELLULOSE SULFATE (UNII: VR47YBL2QJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69499-354-60 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 07/06/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value scoring 1 shape size (solid drugs) 22 mm color Labeler - Solubiomix, LLC (079640556)