HYLAVITE Tablets Dietary Supplement
Dispensed by Prescription†
| Supplement Facts
Serving Size: 1 Tablet Serving Per Container: 30 | ||
| Amount Per Serving | % Daily Value | |
| 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% |
| Folic Acid (1mg Folic Acid) | 1666 mcg DFE | 417% |
| Vitamin B12 (as methylcobalamin) | 6 mcg | 250% |
| Biotin | 300 mcg | 1000% |
| Pantothenic Acid (as d-calcium pantothenate) | 10 mg | 200% |
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.
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.
KEEP OUT OF THE 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.
