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Optinate tablets

Description

OptiNate™ is a prescription prenatal/postnatal multivitamin/mineral capsule and tablet combination with essential fatty acids. The prenatal vitamin tablet is a white oval oil- and water-soluble multivitamin/multimineral film-coated tablet debossed with "PN" on one side. The essential fatty acid L-Vcaps™ are clear oval capsules containing light yellow to dark orange semi-solid mixture, and are imprinted with a leaf encircling "DHA-250" on one side.

Each tablet contains:

  Elemental Iron (carbonyl iron) ......... 90 mg

  Biotin .......... 30 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

  Folate  1 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) ....................... 3 mg

  Vitamin B 2 (riboflavin, USP) ............................ 3.4 mg

  Vitamin B 6 (pyridoxine HCl) ............................. 20 mg

  Vitamin B 12 (cyanocobalamin) ........................ 12 mcg

  Niacinamide, USP ............................................ 20 mg

  Magnesium (magnesium oxide, USP) ................ 30 mg

  Docusate Sodium, USP .................................... 50 mg

Each L-Vcaps™ Capsule contains:

Docosahexaenoic Acid (DHA)  250 mg

DHA is contained in the oil derived from microalgae.

*USP Compliance: OptiNate™ is formulated to comply with official U.S. Pharmacopeia (USP) standards of quality for potency, purity and dissolution. The prenatal vitamin tablet meets the USP standard for folic acid dissolution.

Other Ingredients (OptiNate™ Omega-3 L-Vcaps™): Hypromellose, iron oxide, beeswax, ascorbyl palmitate, mixed tocopherols, and other ingredients.

Other Ingredients (OptiNate™ Tablets):   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

OptiNate™ 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. OptiNate™ can also be beneficial in improving the nutritional status of women prior to conception.

Contraindications

These products are contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

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

Before, during, and after pregnancy, one tablet and one L-Vcaps™ capsule daily, or as directed by a physician. Caution should be exercised to ensure that the prescribed dosage of DHA does not exceed 1 gram (1,000 mg) per day.

How Supplied

Child-resistant blister packs of 5 tablets and 5 L-Vcaps™ -- NDC 59630-412-30.

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

Prenatal Vitamin Supplements Manufactured by:

Patheon Inc.

Mississauga, ON L5N 7K9

Made in Canada

Omega-3 L-Vcaps™ Manufactured by:

Capsugel

535 North Emerald Road

Greenwood, SC 29646

U.S. Patents #5,997,915, #6,254,904, #6,011,040.

Metafolin is a registered trademark of Merck KGaA, Germany.

L-Vcaps™ is a trademark of Capsugel.

For inquiries call 1-800-849-9707 OPT-PI-01

Rev. 12/04

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