DAYAVITE- coenzyme q10, alpha-lipoic acid, ascorbic acid, beta-carotene, cholecalciferol, chromium, copper, d-alpha tocopheryl acid, folic acid, magnesium, manganese, methylcobalamin, molybdenum amino acid, niacinamide, potassium, pyridoxine, riboflavin, selenium, thiamine, zinc tablet, coated

Dayavite by

Drug Labeling and Warnings

Dayavite by is a Other medication manufactured, distributed, or labeled by Amella Pharma, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM:DAYAVITE Tablets Dietary Supplement Dispensed by Prescription†

Supplement Facts
Serving Size:1 Tablet		Serving per container: 30
Amount Per Serving		% Daily Value
Vitamin A (as Retinyl Palmitate, Beta-Carotene)	750 mcg	83%
Vitamin C (as Ascorbic Acid, Acerola Fruit Extract)	75 mg	83%
Vitamin D (as Cholecalciferol)	25 mcg (1000 IU)	125%
Vitamin E (as D-Alpha Tocopheryl Acid Succinate)	20.1 mg	134%
Thiamine (as Thiamine Mononitrate)	15 mg	1250%
Riboflavin	15 mg	1154%
Niacin (as Niacinamide)	20 mg	125%
Vitamin B6 (as Pyridoxine HCl)	17.5 mg	1029%
Folate	1666 mcg DFE	417%
	(1 mg Folic Acid)
Vitamin B12 (as Methylcobalamin)	50 mcg	2083%
Iodine (as Potassium Iodide)	75 mcg	50%
Magnesium (as Magnesium Oxide)	200 mg	48%
Zinc (as Zinc Gluconate)	7.5 mg	68%
Selenium (as Selenium Chelate)	35 mcg	64%
Copper (as Copper Bisglycinate Chelate)	1 mg	111%
Manganese (as Manganese Bisglycinate Chelate)	2.5 mg	109%
Chromium (as Chromium Polynicotinate)	100 mcg	286%
Molybdenum (as Molybdenum Amino Acid Chelate)	37.5 mcg	83%
Alpha-Lipoic Acid	75 mg	**
Coenzyme Q10	10 mg	**
** Daily Value not established

OTHER INGREDIENTS: Croscarmellose Sodium, Film Coating (Polyvinyl Alcohol, Polyethylene Glycol, Titanium Dioxide, Talc, FD&C Red #40, FD&C Yellow #6), Stearic Acid, Calcium Carbonate, Pharmaceutical Glaze, Microcrystalline Cellulose, Magnesium Stearate, Mono-and Diglycerides, Silicon Dioxide.

DESCRIPTION

DAYAVITE Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

DAYAVITE is a long, oblong, dark pink, clear-coated tablet, with debossed "A3” on one side.

PRECAUTIONS

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

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

DAYAVITE Tablets should only be used under the direction and supervision of a licensed medical practitioner. Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

Folic acid supplementation may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations progress.

WARNINGS

KEEP OUT OF REACH OF CHILDREN.

Pregnancy and Lactation:
DAYAVITE Tablets is not intended for use in pregnant or lactating patients.

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 tablet by mouth once daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

DAYAVITE Tablets are supplied as a long, oblong, dark pink, clear-coated tablet, with debossed "A3” on one side.
DAYAVITE Tablets is available as the following:
72287-0663-30*       30ct       bottle

Store at 20° to 25°C (68° to 77°F; excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]

Manufactured for:
Amella Pharma, LLC
E Brunswick, NJ 08816

Call your doctor for medical advice about side effects. You may report side effects to Amella Pharma, LLC at 1-844-385-0850.

Issued: 04/2021 AP11002v1

*Amella Pharma does not represent these product codes to 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). The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx). 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)

Packaging

INGREDIENTS AND APPEARANCE

DAYAVITE 
coenzyme q10, alpha-lipoic acid, ascorbic acid, beta-carotene, cholecalciferol, chromium, copper, d-alpha tocopheryl acid, folic acid, magnesium, manganese, methylcobalamin, molybdenum amino acid, niacinamide, potassium, pyridoxine, riboflavin, selenium, thiamine, zinc tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:72287-663
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	750 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	75 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	25 ug
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL SUCCINATE, D-	20.1 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	15 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	15 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	17.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	50 ug
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	75 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	200 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	7.5 mg
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	35 ug
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	1 mg
MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P)	MANGANESE	2.5 mg
CHROMIUM NICOTINATE (UNII: A150AY412V) (NIACIN - UNII:2679MF687A)	CHROMIUM NICOTINATE	100 ug
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U)	MOLYBDENUM	37.5 ug
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y)	ALPHA LIPOIC ACID	75 mg
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	10 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SHELLAC (UNII: 46N107B71O)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72287-663-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/14/2021

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	19 mm
scoring	1
imprint

Labeler - Amella Pharma, Llc (081189492)