DEXIVITE- ascorbic acid, cholecalciferol, thiamine, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferro

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:

Lifsa Drugs Llc

Administration route:

ORAL

Therapeutic indications:

Dexivite 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. Dexivite Tablets may be useful in improving the nutritional status of women prior to conception.

Product summary:

Dexivite Tablets are available as white, round tablets and are available in 30-count bottles (72336-044-01*). This product is not an Orange Book product. Dispensed by Prescription† Manufactured for: Lifsa Drugs LLC, New Brunswick, NJ 08901 Rev. 08/19 * Lifsa Drugs LLC 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

DEXIVITE- ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE,
PYRIDOXAL-5-PHOSPHATE, FOLIC ACID,
METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, IODINE TABLET
LIFSA DRUGS LLC
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DEXIVITE
HEALTH CLAIM:
Dexivite Tablets - Prenatal/Postnatal Dietary Supplement
Dispensed by Prescription
SUPPLEMENT FACTS
SERVING SIZE: 1 TABLET
Serving per Bottle: 30
AMOUNT PER SERVING:
% DAILY VALUE
Vitamin C (as ascorbic acid)
125 mg
104%
Vitamin D3 (as cholecalciferol)
12.5 mcg (500 IU)
83%
Thiamine (Vitamin B1 as thiamine HCl)
1.4 mg
100%
Vitamin B6 (as pyridoxal-5-phosphate)
2.5 mg
125%
Folic Acid
1,666 DFE (1 mg folic acid)
278%
Vitamin B12 (as methylcobalamin)
1,000 mcg
35,714%
Calcium (from calcium carbonate)
200 mg
15%
Iron (as ferrous gluconate)
13 mg
48%
Iodine (as potassium iodide)
150 mcg
52%
OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide and
Magnesium Stearate.
DESCRIPTION:
Dexivite 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. Dexivite
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.
CONTRAINDICATIONS:
Dexivite 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. Dexivite
Tablets should only be used under the direction