HEALTH CLAIM:
Amladex Tablets Dietary Supplement
Dispensed by Prescription†
| 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 | 1.667 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, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate..
DESCRIPTION:
Amladex 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.
Amladex should be administered under the supervision of a licensed medical practitioner.
WARNING AND PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Amladex 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.
DOSAGE & ADMINISTRATION
Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner.
INDICATIONS AND USAGE
Amladex 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:
Amladex 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:
Misemer Pharmaceuticals, Inc.
Ripley, MS 38663
Rev. 11/21
