HYLAVITE- thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, biotin, pantothenic acid, vitamin c tablet, coated

HYLAVITE by

Drug Labeling and Warnings

HYLAVITE by is a Other medication manufactured, distributed, or labeled by AMELLA PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYLAVITE Tablets Dietary SupplementDispensed by Prescription†

Supplement Facts; Serving Size: 1 Tablet          Serving per container: 30
Amount Per Serving		% Daily Value
Vitamin C (as ascorbic Acid)	100 mg	167%
Thiamine (as thiamine mononitrate)	1.5 mg	100%
Riboflavin	1.7 mg	100%
Niacin (as niacinamide)	20 mg	100%
Vitamin B6 (as pyridoxine HCl)	10 mg	500%
Folic Acid	1 mg	250%
Vitamin B12 (as methylcobalamin)	6 mcg	100%
Biotin	300 mcg	100%
Pantothenic Acid (as d-calcium pantothenate)	10 mg	100%

OTHER INGREDIENTS: Microcrystalline Cellulose, Croscarmellose Sodium, Pharmaceutical Glaze, Mono- and Diglycerides, Starch, Calcium Stearate.

DESCRIPTION

HYLAVITE 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.

HYLAVITE is a small, round, yellow, clear-coated tablet, with debossed "A" 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.

HYLAVITE 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:
HYLAVITE 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 or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED HEALTH CLAIM:

HYLAVITE Tablets are supplied as a small, round, yellow, clear-coated tablet, with debossed "A" on one side.

HYLAVITE Tablets is available as the following:
72287-221-30*    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: 11/2018    AP2002v3

*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.

Packaging

INGREDIENTS AND APPEARANCE

HYLAVITE 
thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, biotin, pantothenic acid, vitamin c tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:72287-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	6 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	300 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	10 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SHELLAC (UNII: 46N107B71O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM STEARATE (UNII: 776XM7047L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72287-221-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		09/26/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	11 mm
scoring	1
imprint

Labeler - AMELLA PHARMA, LLC (081189492)