Label: AZESCO- ascorbic acid, cholecalciferol, thiamin, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet
- NDC Code(s): 69499-344-30
- Packager: Solubiomix
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated October 3, 2019
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- HEALTH CLAIM:
Azezco Tablets - Prenatal/Postnatal 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 mg 15% Iron (as ferrous gluconate) 13 mg 48% Iodine (as potassium iodide) 150 mcg 52%
OTHER INGREDIENTS: cellulose, magnesium stearate, and silicon dioxide.Close
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.Close
- 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.
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.Close
- DOSAGE & ADMINISTRATION
Usual adult dose is 1 tablet taken orally once or twice daily or as prescribed by a licensed medical practitioner.Close
- 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
*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)Close
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.
Madisonville, LA 70447
- PACKAGE LABEL:
- INGREDIENTS AND APPEARANCE
ascorbic acid, cholecalciferol, thiamin, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69499-344 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 125 mg cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol 0.0125 mg THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.4 mg PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 2.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 1 mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 13 mg POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION .15 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69499-344-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/01/2019 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape imprint size (solid drugs) 19 mm scoring 1 Labeler - Solubiomix (079640556)