RELCARE- vitamin tablet, coated

Relcare by

Drug Labeling and Warnings

Relcare by is a Other medication manufactured, distributed, or labeled by Allegis Pharmaceuticals, LLC, Formulation Technology Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Suplement Facts

Other Ingredients:

Microcrystalline cellulose, powder cellulose,vegetable stearic acid, silica, croscarmellose sodium, vegetable megnesium stearate, hydroxypropyl methylcellulose (HPMC), titanium oxide. 

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamine B12 is deficient.  

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.  Relcare Tablets should only be used under the direction and supervision of a licensed medical practitioner. 

Contraindications

Relcare Tablets are contraindicated in patients with a know hypersensitivity to any of the contained ingredients.  Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner. 

Warnings

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.  

For use under the supervision of a licensed medical practitioner.  

Dispense in a tight, light resistant container as defined in the USP/NF in a child-resistant closure.  

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling Allegis Pharmaceuticals at 1-866-633-9033 or the FDA by calling 1-800-FDA-1088

Dosage and Adminstration

Description: Relcare Tablets is a prescription dietary supplement intended for oral adminstration.

Indication and Usage: Relcare Tablets is to privide significant amounts of Vitamins B6, B12, D3, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitaines will not develop. 

Dosage: Usual adult dose is one tablet daily, or as prescribed by a licensed medical practitioner.

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture.Tamper Evident: Do not use if seal if broken or missing.

Statements

† 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. 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 FR20750) 2. Federal Register Notice of October 17, 1980 (45 FR69043, 69044)  3. Federal Register Notice of March 5, 1996 (61 FR 8760)

Label

How Supplied

Relcare Tablets: Each bottle contains 30 tablets (white) (28595-719-30)

Relcare Tablets are avaiable as white, round tablets with F100 imprint and are available in 30 count bottles (28595-719-30)

These Statements have note been evaluated by the FDA.  This product is not intended to diagnose, treat, cure, or prevent any disease. 

Manufactured in the USA for:

Allegis Pharmaceuticals, LLC

Canton, MS  39046

Rev 03/2025

INGREDIENTS AND APPEARANCE

RELCARE 
vitamin tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:28595-719
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	4.5 ug
N-ACETYL-L-CYSTEINE 2-DEOXY-3-THIO-D-ERYTHRO-PENTONIC ACID .GAMMA.-LACTONE THIOETHER (UNII: KX2B81V402) (N-ACETYL-L-CYSTEINE 2-DEOXY-3-THIO-D-ERYTHRO-PENTONIC ACID .GAMMA.-LACTONE THIOETHER - UNII:KX2B81V402)	N-ACETYL-L-CYSTEINE 2-DEOXY-3-THIO-D-ERYTHRO-PENTONIC ACID .GAMMA.-LACTONE THIOETHER	150 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	20 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1667 ug

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICA (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:28595-719-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		04/16/2025

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	11 mm
imprint
scoring	1

Labeler - Allegis Pharmaceuticals, LLC (792272861)

Establishment
Name	Address	ID/FEI	Business Operations
Formulation Technology Incorporated		062525910	manufacture