Label: FOLTRATE- folic acid and cyanocobalamin tablet, film coated

  • NDC Code(s): 50991-323-01, 50991-323-25
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 12, 2024

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  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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 CARTON08/26/201008/26/2010
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50991-323-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/26/201008/26/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/26/201008/26/2010
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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