Remedient

Product Overview

Brand: Levins Pharma

Barcode: 3 71905 10230 5

Net Contents: 30 Capsule(s)

Serving Size (Overview): 1 Capsule(s)

Product Type: Other Combinations [A1325]

Form: Capsule [E0159]

Date Entered: Jul 23, 2020

Market Status: On Market

Suggested Use (Overview): Dosage and 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.

Product Self-Roles:

No specific self-roles defined.

Dietary Supplement Facts

Ingredient	Category	Amount Per Serving	Unit	% Daily Value	Target Group	Serving Size (Fact)
Vitamin C	vitamin	200	mg	222	Adults and children 4 or more years of age	1 Capsule(s)
Vitamin D3	vitamin	20	mcg	100	Adults and children 4 or more years of age	1 Capsule(s)
Folic Acid	vitamin	1667	mcg DFE	417	Adults and children 4 or more years of age	1 Capsule(s)
Vitamin B12	vitamin	6	mcg	250	Adults and children 4 or more years of age	1 Capsule(s)
Calcium	mineral	40	mg	3	Adults and children 4 or more years of age	1 Capsule(s)
Iron	mineral	3.6	mg	20	Adults and children 4 or more years of age	1 Capsule(s)
Magnesium Glycinate Glutamine Chelate	non-nutrient/non-botanical	8.5	mg	2	Adults and children 4 or more years of age	1 Capsule(s)
Magnesium Oxide	mineral	60.3	mg	14	Adults and children 4 or more years of age	1 Capsule(s)
Zinc	mineral	8	mg	73	Adults and children 4 or more years of age	1 Capsule(s)
PepZin GI	non-nutrient/non-botanical	37.5	mg	N/A	Adults and children 4 or more years of age	1 Capsule(s)
L-Carnosine	non-nutrient/non-botanical	28	mg	N/A	Adults and children 4 or more years of age	1 Capsule(s)

Other Ingredients

Microcrystalline Cellulose; Magnesium Stearate; Silica; Gelatin; Titanium Dioxide; FD&C Blue 1

Label Statements

Statement of Identity

Dietary Supplement 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.

Other

Dispensed by prescription For product information peel here 1. Federal Register Notice of August 2 1973 (38 FR 207502. Federal Register Notice of October 17 1980 (45 FR 69043 69044)3. Federal Register Notice of March 5 1996 (61 FR 8760) 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 cods 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.

Suggested Use

Dosage and 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.

Precautions

Keep out of reach of children Allergens: Milk (casein) 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. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.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 medication. Use with caution in patients that may have a medical condition are pregnant lactating trying to conceive under the age of 18 or taking medication. Tamper evident: Do not use if seal is broken or missingTo report adverse events or to obtain product information contact 228-392-0043.

Product Specific Information

Storage and Handling: Store as 20 degrees-25 degrees C (68 degrees-77 degrees F); excursions permitted to 15 degrees-30 degrees C (59 degrees-86 degrees F) [See USP Controlled Room Temperature.]Protect from heat light and moisture.

Formulation

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.