Label: PRENARA capsule

  • NDC Code(s): 69336-352-30
  • Packager: Sterling-Knight Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 3, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION:

    Prenara is an orally administered prescription dietary supplement formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.
    Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years.
    Prenara should be administered under the supervision of a licensed medical practitioner.

    Each softgel capsule contains:

    supplfacts

    Other Ingredients: Soybean oil, gelatin (bovine), bees wax (yellow), lecithin, glycerin, deionized water, FD&C red #40, FD&C blue #1, titanium dioxide.

  • INDICATIONS AND USAGE:

    Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years

  • CONTRAINDICATIONS:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.


    Prenara 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.

  • WARNINGS AND PRECAUTIONS:

    This product should be administered with caution in patients with a history of liver disease, jaundice or diabetes mellitus.

    Folic acid above 1mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

  • ADVERSE REACTION:

    Allergic sensitization has been reported following both oral and parental administration of folic acid.

  • DOSAGE AND ADMINISTRATION:

    Usual dose is 1 to 2 capsules daily or as prescribed by licensed medical practitioner.

  • HOW SUPPLIED:

    Prenara is supplied as a purple softgel capsules with 352 printed and dispensed in white HDPE plastic bottles of 30ct.

    69336-352-30

  • STORAGE:

    Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.

  • SPL UNCLASSIFIED SECTION

    Reserved for Professional Recommendation

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

    Manufactured for:
    Sterling-Knight Pharmaceuticals, LLC
    Ripley, MS 38663


    Item 35230                  Rev. 0320-1

  • PRINCIPAL DISPLAY PANEL

    Prenara Label

    prenaralabel

  • PRINCIPAL DISPLAY PANEL

    Prenara Carton

    prenaracarton

  • INGREDIENTS AND APPEARANCE
    PRENARA 
    prenara capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69336-352
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D750 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.8 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 HYDROCHLORIDE2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.5 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM100 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.15 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM15 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC20 mg
    Product Characteristics
    ColorpurpleScoreno score
    ShapecapsuleSize11mm
    FlavorImprint Code 352
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69336-352-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/09/2020
    Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sterling-Knight Pharmaceuticals, LLC079556942manufacture(69336-352) , label(69336-352)