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Prenate Elite Tablets (First Horizon)



  • Description
  • Indications and Usage
  • Contraindications
  • Warnings
  • Precautions
  • Adverse Reactions
  • Dosage and Administration
  • How Supplied



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  • DESCRIPTION

    PRENATE ELITE™ is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with "PN" on one side.

    Each tablet contains:

    Elemental Iron (carbonyl iron)90 mg

    Biotin30 mcg

    Pantothenic acid (calcium pantothenate, USP)6 mg

    Calcium (calcium carbonate, USP)200 mg

    Copper (cupric oxide)2 mg

    Zinc (zinc oxide, USP)15 mg

    Folate1 mg

      (L-methylfolate as Metafolin® 600 mcg)

      (folic acid, USP 400 mcg)

    Vitamin D 3 (cholecalciferol)400 IU

    Vitamin E (dl-alpha tocopheryl acetate)10 IU

    Vitamin C (ascorbic acid, USP)120 mg

    Vitamin B 1 (thiamine mononitrate, USP)3 mg

    Vitamin B 2 (riboflavin, USP)3.4 mg

    Vitamin B 6 (pyridoxine HCl)20 mg

    Vitamin B 12 (cyanocobalamin)12 mcg

    Niacinamide, USP20 mg

    Magnesium (magnesium oxide, USP)30 mg

    Docusate Sodium, USP50 mg

    Other Ingredients:   calcium phosphate dibasic, carnauba wax, crospovidone, dextrin, dl-alpha tocopherol, gelatin, hypromellose, lactose, magnesium stearate, mono and diglycerides, polacrilin, pregelatinized starch, propylene glycol, silicon dioxide, sodium benzoate, partially hydrogenated soybean oil, starch, stearic acid, sucrose, titanium dioxide, and other ingredients.

    INDICATIONS

    PRENATE ELITE™ is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE ELITE™ can also be beneficial in improving the nutritional status of women prior to conception.

    CONTRAINDICATIONS

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

    WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

    PRECAUTIONS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

    ADVERSE REACTIONS

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

    DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

    HOW SUPPLIED

    Child-resistant unit-dose packs of 90 geltabs

    NDC 59630-411-90

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]

    NOTICE:   Contact with moisture may produce surface discoloration and/or erosion of the tablet.

    First Horizon Pharmaceutical® CORPORATION

    Manufactured for

    First Horizon Pharmaceutical® Corporation

    Alpharetta, GA 30005

    Manufactured by Patheon Inc.

    Mississauga, ON L5N 7K9

    Made in Canada

    For inquiries call 1-800-849-9707








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    This page was last modified 30-JUN-07
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