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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel NDC 50991-323-01 Foltrate Tablets Each tablet contains: Folic Acid 1.0 mg Vitamin B-12 500 mcg Rx ONLY