Label: XYZBAC- ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal 5 phosphate, folic acid, methylcobalamin, adenine dinucleotide, ubiquinone tablet
- NDC Code(s): 69597-314-30
- Packager: Basiem
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated October 11, 2018
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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.
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
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 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.
- Federal Register Notice of August 2, 1973 (38 FR 20750)
- Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
- Federal Register Notice of March 5, 1996 (61 FR 8760)
STORAGE AND HANDLING:
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.
KEEP OUT OF THE REACH OF CHILDREN.
Tamper Evident: Do not use if seal is broken or missing.
To report adverse side effects or to obtain product information, contact Basiem, LLC at 1-844-551-9911
- PACKAGE LABEL:
INGREDIENTS AND APPEARANCE
ascorbic acid, cholecalciferol, thiamin hcl, pyridoxal 5 phosphate, folic acid, methylcobalamin, adenine dinucleotide, ubiquinone tablet
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69597-314 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 500 [iU] THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 25 mg PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 12.5 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 1 mg NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH 5 mg COENZYME Q10, (2Z)- (UNII: U705VLF0VW) (COENZYME Q10, (2Z)- - UNII:U705VLF0VW) COENZYME Q10, (2Z)- 50 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:69597-314-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 03/22/2016 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape imprint size (solid drugs) 19 mm scoring 1 Labeler - Basiem (079686680)