REMEDIENT- ascorbic acid, cholecalciferol, folic acid, cyanocobalamin, calcium citrate, iron protein succinylate, magnesium glycinate glutamine chelate, magnesium oxide, zinc, zinc-l carnosine complex, l-carnosine capsule

Remedient by

Drug Labeling and Warnings

Remedient by is a Other medication manufactured, distributed, or labeled by Levins Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

STATEMENT OF IDENTITY

Remedient™ Capsules Dietary Supplement

HEALTH CLAIM

Dispensed by Prescription†

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. ††

†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 B12
deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). 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)

†† 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

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

PRECAUTIONS

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

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

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.

INGREDIENTS AND APPEARANCE

REMEDIENT 
ascorbic acid, cholecalciferol, folic acid, cyanocobalamin, calcium citrate, iron protein succinylate, magnesium glycinate glutamine chelate, magnesium oxide, zinc, zinc-l carnosine complex, l-carnosine capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:71905-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	200 mg
Vitamin D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41)	Vitamin D	20 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1667 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	6 ug
CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CITRATE ANHYDROUS	40 mg
IRON PROTEIN SUCCINYLATE (UNII: VBJ9L90P4L) (IRON PROTEIN SUCCINYLATE - UNII:VBJ9L90P4L)	IRON PROTEIN SUCCINYLATE	3.6 mg
MAGNESIUM GLYCINATE (UNII: IFN18A4Y6B) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLYCINATE	8.5 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	60.3 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	8 mg
POLAPREZINC (UNII: 0WA1B15A1Z) (POLAPREZINC - UNII:0WA1B15A1Z)	POLAPREZINC	37.5 mg
CARNOSINE (UNII: 8HO6PVN24W) (CARNOSINE - UNII:8HO6PVN24W)	CARNOSINE	28 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:71905-102-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		07/19/2019

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
color
shape
size (solid drugs)	21 mm
scoring	1

Labeler - Levins Pharmaceuticals, LLC (080839485)

Registrant - Levins Pharmaceuticals, LLC (080839485)