Label: OMNIVEX tablet
- NHRIC Code(s): 69336-360-30
- Packager: Sterling Knight Pharmaceuticals LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated April 24, 2018
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HEALTH CLAIM:
Omnivex 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% Vitamin B1 (as Thiamin HCl) 25 mg 1,667% Vitamin B6 (as pyridoxal phosphate anhydrous) 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: Microcrystalline Cellulose, Pregelatinized Corn Starch, Coating (Beta-Carotene, Titanium Dioxide, Hypromellose, Polyvinyl Alcohol, Polyethylene Glycol, talc), Croscarmellose Sodium, Silica, Silicon Dioxide, Hydroxypropyl Cellulose, Magnesium Stearate..
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DESCRIPTION:
Omnivex 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.
Omnivex should be administered under the supervision of a licensed medical practitioner.
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WARNING AND PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Omnivex 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.
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DOSAGE & ADMINISTRATION
Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner.
INDICATIONS AND USAGE
Omnivex 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. -
HOW SUPPLIED HEALTH CLAIM:
Omnivex is supplied as a clear coated oblong tablet dispensed in HDPE plastic bottles of 30ct.
Dispensed by Prescription†
Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
† 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.
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)
Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663
Item 36030
Rev. 0418-2
- STORAGE AND HANDLING:
- PACKAGE LABEL:
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INGREDIENTS AND APPEARANCE
OMNIVEX
omnivex tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69336-360 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) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYDRATED SILICA (UNII: Y6O7T4G8P9) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) .BETA.-CAROTENE (UNII: 01YAE03M7J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69336-360-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 04/16/2018 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 19 mm scoring 1 Labeler - Sterling Knight Pharmaceuticals LLC (079556942)