FOLITE- folic acid, magnesium citrate, calcium citrate, vitamin d3, n-acetyl-l-cysteine tablet 
Poly Pharmaceuticals, Inc.

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Folite Tablet

Description

Folite Tablets is a dietary supplement intended for oral administration

Indication and Usage

Folite is indicated for folic acid supplementation and general nutritional support. May also be recommended for patients who are of advancing
age or suffer from improper food intake.

Precaution

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Warnings

KEEP THIS AN ALL MEDICATION OUT OF REACH OF CHILDREN.

For use under the supervision of a licensed physician. Dispense in a tight, light resistant container as defined in the USP/NF with a child-resistant closure.

Storage

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature|
Protect from light and moisture.

Dosage and Administration

Adults-one tablet daily or as directed by physician.

Safety and effectiveness in pediatric patients have not been established.

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

image description

FOLITE 
folic acid, magnesium citrate, calcium citrate, vitamin d3, n-acetyl-l-cysteine tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:50991-977
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLCYSTEINE (UNII: WYQ7N0BPYC) 200 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) 50 [iU]
CALCIUM CITRATE (UNII: MLM29U2X85) 30 mg
MAGNESIUM CITRATE (UNII: RHO26O1T9V) 30 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:50991-977-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement06/01/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
scoring2
color
size (solid drugs)19 mm
shape
imprint
Labeler - Poly Pharmaceuticals, Inc. (198449894)
Registrant - Poly Pharmaceuticals, Inc. (198449894)
Establishment
NameAddressID/FEIBusiness Operations
Formulation Technology Incorporated062525910manufacture

Revised: 8/2019
Document Id: 9a506677-ab82-43e9-9d00-5eb8318ea4c2
Set id: c6589bc2-9237-414d-89dd-619725f41eab
Version: 3
Effective Time: 20190805
 
Poly Pharmaceuticals, Inc.