NITRIVIA- niacin, folate, calcium, l-arginine, l-ornithine, beet, gotu kola, carrot, celery extract capsule

NITRIVIA by

Drug Labeling and Warnings

NITRIVIA by is a Other medication manufactured, distributed, or labeled by Solubiomix, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)	100 mg	625%
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.

Gluten Free

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.

DOSAGE

Usual adult dose is 2 capsule once or twice daily, or as prescribed by a licensed medical practitioner.

If you are pregnant or nursing, ask a healthcare professional.

NITRIVIA should be administered under the supervision of a licensed medical practitioner.‡

SAFE HANDLING

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.

ADVERSE REACTIONS
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.

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture.

Tamper Evident: Do not use if seal is broken or missing.

HOW SUPPLIED HEALTH CLAIM

NITRIVIA, Nitric Oxide Health

Dietary Supplement

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:

Solubiomix, LLC

Madisonville, LA  70447

Rev. 07/2023

# 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

NITRIVIA 
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)