Label: ZIPHEX- ascorbic acid, cholecalciferol, thiamin, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet
- NHRIC Code(s): 73308-344-30
- Packager: Ayurax
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated March 17, 2022
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ZIPHEX 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 mg 15% Iron (as ferrous gluconate) 13 mg 48% Iodine (as potassium iodide) 150 mcg 52%
OTHER INGREDIENTS: cellulose, magnesium stearate, and silicon dioxide.
ZIPHEX 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.
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.
CONTRAINDICATIONS ZIPHEX 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. ZIPHEX Tablets should only be used under the direction and supervision of a licensed medical practitioner.
- ADVERSE REACTIONS
- DOSAGE & ADMINISTRATION
HOW SUPPLIED HEALTH CLAIM:
ZIPHEX Tablets are available as tan, oblong tablets imprinted "0344" and are available in 30-count bottles (73308-344-30*). This product is not an Orange Book product.
Dispensed by Prescription†
MADE IN USA
*Ayurax 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.
Fairhope, AL 36532
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:73308-344 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:73308-344-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 03/17/2022 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape imprint size (solid drugs) 19 mm scoring 1 Labeler - Ayurax (117147643) Establishment Name Address ID/FEI Business Operations New Generation Wellness 806784679 manufacture