TRIADVANCE- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, and docusate sodium tablet
Trigen Laboratories, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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TriAdvance
Prenatal Vitamin Tablets
Rx Only
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.
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.
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
| TRIADVANCE
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, and docusate sodium tablet |
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| Labeler - Trigen Laboratories, LLC (830479668) |