Remedient

Basic Information

Product Label

Product label for Remedient
Full Name: Remedient
Brand: Levins Pharma none
Product Type: Other Combinations
Physical State: Capsule
UPC/SKU: 3 71905 10230 5
Product Version Code: 71905-0102-30 Rev. 07/19

Contact Information

Manufactured for

Name: Levins Pharmaceuticals, LLC
Address:15121 Lemoyne Blvd, Biloxi, MS, 39532
Types: Distributor

Product Details

Net Contents

30 Capsule(s)(30 Capsule(s))

Serving Sizes

Unit:Capsule(s)
Quantity:1 - 1
Daily Servings:1 - 2

Target Groups

Adult (18 - 50 Years)

Servings Per Container

30

Ingredients & Nutrition

CalcIum

mineral

Group: Calcium

Carnosine

non-nutrient/non-botanical

Group: Carnosine

Also known as: L-Carnosine

Group: Color

UNII Code: H3R47K3TBD

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Group: Collagen

Hydrolyzed collagen is a form of collagen that has been broken down into smaller peptides, ensuring ease of digestion and absorption in the human body. Collagen is the most abundant protein in the body and is essential for maintaining healthy skin, bones, and connective tissues. Hydrolyzed collagen is often used as a supplement to support skin health, joint health, and overall wellness.

Also known as: Gelatin

L-Carnosine

non-nutrient/non-botanical

Group: Carnosine

Also known as: CarnoSure

UNII Code: 8HO6PVN24W

Magnesium Glycinate Glutamine Chelate

non-nutrient/non-botanical

Group: Magnesium

Group: Magnesium

Also known as: Mg Oxide

UNII Code: 3A3U0GI71G

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

PepZin GI

non-nutrient/non-botanical

Group: Proprietary Blend (Combination)

Also known as: Zinc-L-Carnosine Complex

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin D3

vitamin

Group: Vitamin D

Vitamin D3, also known as cholecalciferol, is a fat-soluble vitamin that plays a crucial role in bone health by aiding in the absorption of calcium and phosphorus in the body. It can be produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Additionally, Vitamin D3 is found in dietary supplements and fortified foods to help maintain adequate levels for optimal health.

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Zinc L-Carnosine

non-nutrient/non-botanical

Group: Zinc-l-Carnosine

Also known as: PepZin GI, Zn L-Carnosine

UNII Code: 0WA1B15A1Z

Product Statements

FDA Statement of Identity

Dietary Supplement

General Statements: All Other Content

Dispensed by prescription

Suggested/Recommended/Usage/Directions

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 re: Children

Keep out of reach of children

Storage

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.

Precautions re: Allergies

Allergens: Milk (casein)

General Statements: All Other Content

For product information peel here

Formulation re: Other

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.

Precautions re: All Other

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.

General Statements: All Other Content

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)

FDA Disclaimer Statement

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.

Precautions re: All Other

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.

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: Children

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.

General Statements: All Other Content

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.

Precautions re: All Other

Tamper evident: Do not use if seal is broken or missing To report adverse events or to obtain product information, contact 228-392-0043.

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