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TriAdvance (beta carotene 2700 [iu] ascorbic acid 120 mg cholecalciferol 400 [iu] .alpha.-tocopherol acetate, dl- 30 [iu] thiamine mononitrate 3 mg riboflavin 3.4 mg niacinamide 20 mg pyridoxine hydrochloride 20 mg folic acid 1 mg cyanocobalamin 12 ug calcium carbonate 200 mg iron 90 mg magnesium oxide 30 mg zinc oxide 25 mg cupric oxide 2 mg docusate sodium 50 mg) Dailymed



IMPRINT: TL020     SHAPE: oval
    COLOR: yellow

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Description


TriAdvance is a prescription prenatal multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. It is a yellow-speckled tablet debossed "TL020".

Each tablet for oral administration contains:
Vitamin A (beta-carotene) 2700 I.U.
Vitamin C (ascorbic acid) 120 mg
Vitamin D 3 (cholecalciferol) 400 I.U.
Vitamin E (dl-alpha-tocopheryl acetate) 30 I.U.
Vitamin B 1 (thiamine mononitrate) 3 mg
Vitamin B 2 (riboflavin) 3.4 mg
Niacin (niacinamide) 20 mg
Vitamin B 6 (pyridoxine hydrochloride) 20 mg
Folic Acid 1 mg
Vitamin B 12 (cyanocobalamin) 12 mcg
Calcium (calcium carbonate) 200 mg
Iron (carbonyl iron) 90 mg
Magnesium (magnesium oxide) 30 mg
Zinc (zinc oxide) 25 mg
Copper (cupric oxide) 2 mg
Docusate Sodium 50 mg

Inactive Ingredients: Microcrystalline Cellulose, TriPotassium Citrate, Gum Arabic, Fumed Silica, Croscarmellose Sodium, Citric Acid, Povidone K30, Sodium Carboxymethyl Cellulose, Magnesium Stearate, Stearic Acid, Dextrin, Dextrose, Lecithin, Sodium Citrate.

Indications And Usage


TriAdvance 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. TriAdvance 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.

Warnings


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 remain progressive.

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


General


The calcium content should be considered before prescribing for patients with kidney stones. Do not exceed the recommended dosage.

Pediatric Use


Safety and effectiveness in pediatric patients have not been established.

Geriatric Use


Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy.

Adverse Reactions


Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Dosage And Administration


Usual dosage is one tablet daily, or as prescribed by a physician.

How Supplied


TriAdvance is supplied in bottles of 90 tablets.

NDC 13811-529-90

Storage


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

Note that contact with moisture may produce surface discoloration or erosion of the tablet.


Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

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

Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for: TRIGEN Laboratories, Inc. Sayreville, NJ 08872 www.trigenlab.com

Rev. 05/11

Principal Display Panel


NDC 13811-529-90 Rx Only

TriAdvance

Prenatal Vitamin Tablets

90 TABLETS

TRIGEN LABORATORIES

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