ZIPHEX- ascorbic acid, cholecalciferol, thiamin, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J), PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W), CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6Z

Available from:

Ayurax

Administration route:

ORAL

Therapeutic indications:

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.

Product summary:

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 Rev. 04/2022 *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)

Authorization status:

Dietary Supplement

Summary of Product characteristics

ZIPHEX- ASCORBIC ACID, CHOLECALCIFEROL, THIAMIN,
PYRIDOXAL-5-PHOSPHATE, FOLIC
ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, IODINE
TABLET
AYURAX
----------
ZIPHEX
HEALTH CLAIM
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.
DESCRIPTION:
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.
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. ZIPHEX Tablets should only be
used under the
direction and supervision of a licensed m