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

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated September 15, 2020

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  • 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 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.

  • 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 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.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HYLAVITE 
    thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, biotin, pantothenic acid, vitamin c tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:72287-221
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72287-221-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement09/26/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)11 mm
    scoring1
    imprint
    Labeler - AMELLA PHARMA, LLC (081189492)