Label: AZESCO- ascorbic acid, cholecalciferol, thiamin, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 6, 2019

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

  • HEALTH CLAIM:

    Azezco Tablets - Prenatal/Postnatal/Folate Health Dietary Supplement     

    Dispensed by Prescription

    Supplement Facts
    Serving Size: 1 Tablet

    Servings per Bottle: 30

    Amount Per Serving:% Daily Value
     Vitamin C (as ascorbic acid)  125 mg 104%
     Vitamin D3 (as cholecalciferol)  12.5 mcg 83%
     Thiamin (Vitamin B1 as thiamin HCl) 1.4 mg 100%
     Vitamin B6 (as pyridoxal 5’ phosphate) 2.5 mg 125%
     Folic Acid  1 mg 278%
     Vitamin B12 (as methylcobalamin) 1 mg 3,5714%
    Calcium (from calcium carbonate) 200 mg15%
    Iron (as ferrous gluconate) 13 mg48%
    Iodine (as potassium iodide) 150 mcg52%

    OTHER INGREDIENTS:  cellulose, magnesium stearate, and silicon dioxide.

  • DESCRIPTION:

    Azesco 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.

    Azesco Tablets is a prescription dietary supplement for use throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Azesco Tablets may be useful in improving the nutritional status of women prior to conception.

  • WARNING AND PRECAUTIONS

    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.

    CONTRAINDICATIONSAzesco Tablets are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

    PRECAUTION
    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Azesco Tablets should only be used under the direction and supervision of a licensed medical practitioner.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling 1-844-551-9911 or the FDA by calling 1-800-FDA-1088.

  • DOSAGE & ADMINISTRATION

    Usual adult dose is 1 tablet taken orally once or twice daily or as prescribed by a licensed medical practitioner.

  • HOW SUPPLIED HEALTH CLAIM:

    Azesco Tablets are available as tan, oblong tablets imprinted "0344" and are available in 30-count bottles (69499-344-30*). This product is not an Orange Book product.

    Dispensed by Prescription†

    MADE IN USA
    Rev. 02/19

    *Solubiomix 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).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. 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)

  • STORAGE AND HANDLING:

    STORAGE: Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light and moisture.

    Tamper Evident: Do not use if seal is broken or missing.

    Distributed by:
    Solubiomix, LLC
    Madisonville, LA 70447

  • PACKAGE LABEL:

    image description

  • INGREDIENTS AND APPEARANCE
    AZESCO 
    ascorbic acid, cholecalciferol, thiamin, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69499-344
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
    cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol0.0125 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.4 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION13 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION.15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69499-344-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement02/01/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    imprint
    size (solid drugs)19 mm
    scoring1
    Labeler - Solubiomix (079640556)