Label: HYLAVITE- thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, biotin, pantothenic acid, vitamin c tablet, coated
- NHRIC Code(s): 72287-221-30
- Packager: AMELLA PHARMA, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated September 15, 2020
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HYLAVITE Tablets Dietary SupplementDispensed by Prescription†
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.
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.
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
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
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.
- DOSAGE AND ADMINISTRATION
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]
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.
INGREDIENTS AND APPEARANCE
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)