XYZBAC- ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal 5 phosphate, folic acid, methylcobalamin, adenine dinucleotide, u

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 HYDROCHLORIDE (UNII: M572600E5P) (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), NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916), COENZ

Available from:

Basiem

INN (International Name):

ASCORBIC ACID

Composition:

ASCORBIC ACID 125 mg

Administration route:

ORAL

Therapeutic indications:

Xyzbac 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:

Xyzbac tablets are supplied as tan, oblong shaped tablets with imprint “314”in a child-resistant bottle of 30ct. (69597-314-30*) Dispensed by Prescription† *Basiem 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 (Rx).  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.

Authorization status:

Dietary Supplement

Summary of Product characteristics

XYZBAC- ASCORBIC ACID, CHOLECALCIFEROL, THIAMIN HCL, PYRIDOXAL 5
PHOSPHATE,
FOLIC ACID, METHYLCOBALAMIN, ADENINE DINUCLEOTIDE, UBIQUINONE TABLET
BASIEM
----------
XYZBAC
HEALTH CLAIM
Xyzbac Tablets 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
208%
Vitamin D3 (as cholecalciferol)
500 IU
125%
Thiamin (Vitamin B1 as thiamin HCl)
25 mg
1,667%
Vitamin B6 (as pyridoxal 5’ phosphate)
12.5 mg
625%
Folic Acid
1 mg
250%
Vitamin B12 (as methylcobalamin)
1 mg
16,667%
NADH (reduced nicotinamide-adenine dinucleotide)
5 mg
*
CoEnzyme Q-10 (ubiquinone)
50 mg
*
_*Daily Values (DV) not established._
OTHER INGREDIENTS: cellulose, magnesium stearate, and silicon dioxide.
DESCRIPTION:
Xyzbac 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
This product is contraindicated in patients with a known
hypersensitivity to any of the
ingredients.
Xyzbac tablets should only be used under the direction and supervision
of a licensed
medical practitioner. Use with caution in patients that may have a
medical condition, are
pregnant, lactating, trying to conceive, under the age of 18, or
taking medications.
PREGNANCY AND LACTATION
†
Xyzbac is not intended for use in pregnant or lactating patients.
DOSAGE & ADMINISTRATION
Usual adult dose is 1 tablet once or twice daily or as prescribed by a
licensed medical
practitioner.
HOW SUPPLIED HEALTH CLAIM:
Xyzbac tablets are supplied as tan, oblong shaped tablets with imprint
“314”in a child-
resistant bottle of 30ct. (69597-314-30*)
Dispensed by Prescription
*Basiem does not represent these product codes to be National Drug
Codes (NDC).
Product codes are formatted according to standar