Remedient Dailymed
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Statement Of Identity Section
Remedient™ Capsules Dietary Supplement
Health Claim Section
Dispensed by Prescriptionâ€
Acid-lowering medications can increase pH in the stomach and small intestine, leading to decreased absorption of key vitamins and minerals. Remedient™ is an orally administered prescription vitamin formulation designed to replete these key vitamins and minerals and help support gastro-esophageal health. †â€
†This product is a prescription- folic acid with or without other dietary ingredients that – due to increased folic acid levels increased risk associated with masking of B12deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). The most appropriate way to ensure pedigreereporting 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. Theingredients, 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)
††These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Warnings Section
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions Section
Remedient™ capsules 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 Section
Usual adult dose is one (1) capsule once or twice daily or as prescribed by a licensed medical practitioner. Remedient™ should be taken on an empty stomach for optimal absorption.
Remedient™ capsules are supplied as (purple and white, oblong-shaped) capsules in a child-resistant bottle of 30-count ("71905-0102-30"**).
**Levins Pharmaceuticals 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.
Safe Handling Warning Section
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]
KEEP OUT OF REACH OF CHILDREN
Tamper evident: Do not use if seal is broken or missing
To report adverse events or to obtain product information, contact 228-392-0043.
DISCLAIMER:
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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