PREV-RX- folic acid, vitamin d3, vitamin b12, vitamin e, choline, calcium tablet

Prev-Rx by

Drug Labeling and Warnings

Prev-Rx by is a Other medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc, Formulation Technology Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Prev-Rx is indicated for dietary management of patients with unique nutritional needs requiring increased folate, phosphatidyl choline, Vitamin D3, Vitamin B12 or Vitamin E levels or used in improving the nutritional status of patients with folic acid, phosphatidyl choline, Vitamin D3, Vitamin B12 or Vitamin E deficiency. May also be recommended for patients who are advancing in age and may benefit from supplementation to aid in mental acuity. This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease.

DOSAGE & ADMINISTRATION

Prev-Rx Tablets is an orally administered prescription strength folate product as a dietary supplement.
Prev-Rx should be administered under the supervision of a licensed medical practitioner.

Usual adult dose is 1 tablet daily or as prescribed by a licensed medical practitioner.

HEALTH CLAIM

This product is contraindicated in patients with a known hypersensitivity

WARNINGS

KEEP OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or a poison control center immediately. Safety
and effectiveness in pediatric patients has not been established. Tell your doctor if you have: kidney problems, thyroid disease or heart disease.
This medication should only be used as directed by your doctor during pregnancy or while breastfeeding. Consult your doctor about the risk and benefits. Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological
manifestations progress. There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. Patients with epilepsy controlled by phenytoin may require increased dosing of phenytoin.

PRECAUTIONS

Allergic sensitization has been reported following oral administration of folic acid.

SAFE HANDLING WARNING

Store at 20°-25°C (66° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from
heat, light and moisture.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREV-RX 
folic acid, vitamin d3, vitamin b12, vitamin e, choline, calcium tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:50991-689
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	20 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	25 ug
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL SUCCINATE, D-	10 mg
CHOLINE (UNII: N91BDP6H0X) (CHOLINE - UNII:N91BDP6H0X)	CHOLINE	100 mg
CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM	70 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:50991-689-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		05/09/2025

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

Labeler - Poly Pharmaceuticals, Inc (198449894)

Registrant - Poly Pharmaceuticals, Inc (198449894)

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