FOLTRATE- folic acid and cyanocobalamin tablet, film coated 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Foltrate

Active Ingredients

(each tablet contains)
Folic Acid
Cyanocobalamin (Vitamin B-12) 

Description

Foltrate is a dietary supplement intended for oral administration

Inactive ingredients:

dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silica, magnesium stearate, hydroxypropyl methylcellulose, and polyethylene glycol.

Indications and Usage

Foltrate 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.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 500 mcg of cyanocobalamin (B-12) contained in each tablet of Foltrate should address this precaution.

Adverse reactions

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

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Dosage and Administration

Adults-one tablet daily or as directed by a physician.

How Supplied

Foltrate tablets are round, pink and film-coated. Each tablet is imprinted with "PE" on one side and "122" on the other. Foltrate tablets are available in bottles of 100 Tablets (NDC# 50991-323-01).

WARNING: KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

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

Other information

Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from light and moisture.

Rx only

Manufactured for:
Poly Pharmaceuticals, Inc.
Quitman, MS 39355                                                                                    Rev. 11/11

Principal Display Panel

NDC 50991-323-01

Foltrate

Tablets

Each tablet contains:

Folic Acid 1.0 mg

Vitamin B-12 500 mcg

Rx ONLY label

FOLTRATE 
folic acid and cyanocobalamin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN500 ug
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize10mm
FlavorImprint Code PE;122
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-323-2512 in 1 CARTON08/26/201001/27/2024
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50991-323-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/26/2010
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff3213c-91f8-95f5-e063-6294a90ab3dd
Set id: 8959f9b0-6f9f-40fb-91ae-4af459fe3bcc
Version: 7
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.