HYLAZINC (zinc citrate 50 mg ascorbic acid 100 mg thiamine mononitrate 1.5 mg riboflavin 1.7 mg niacinamide 20 mg pyridoxine hydrochloride 10 mg folic acid 1 mg methylcobalamin 6 ug) Dailymed

Hylazinc Tablets Dietary Supplementdispensed By Prescription

Supplement Facts Serving Size: 1 Tablet          Servings per container: 100
 Amount Per ServingÂ		% 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 Section

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 Section

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, LLCE 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