HYLAZINC- zinc, ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, methylcobalamin, tablet, coated

HYLAZINC by

Drug Labeling and Warnings

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

Drug Details [pdf]

HYLAZINC Tablets Dietary SupplementDispensed by Prescription†

Supplement Facts; Serving Size: 1 Tablet          Servings per container: 100
Amount Per Serving		% Daily Value
Zinc (as Zinc Citrate)	50 mg	455%
Vitamin C (as Ascorbic Acid)	100 mg	111%
Thiamine (as Thiamine Mononitrate)	1.5 mg	125%
Riboflavin	1.7 mg	131%
Niacin (as Niacinamide)	20 mg	125%
Vitamin B6 (as Pyridoxine HCl)	10 mg	588%
Folate	1666 mcg DFE	417%
	(1 mg Folic Acid)
Vitamin B12 (as Methylcobalamin)	6 mcg	250%

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

DESCRIPTION

HYLAZINC 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.

HYLAZINC is a small, round, yellow with yellow specks, clear-coated tablet, with debossed "A2" 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.

HYLAZINC 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:
HYLAZINC 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:

HYLAZINC Tablets are supplied as a small, round, yellow with yellow specks, clear-coated tablet, with debossed "A2" on one side.

HYLAZINC Tablets is available as the following:
72287-0651-01*    100ct       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: 09/2020   AP9002v1

*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

HYLAZINC 
zinc, ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, methylcobalamin, tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:72287-651
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC CITRATE (UNII: K72I3DEX9B) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72287-651-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		09/10/2020

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)