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 D3 (cholecalciferol) | 400 I.U. |
| Vitamin E (dl-alpha-tocopheryl acetate) | 30 I.U. |
| Vitamin B1 (thiamine mononitrate) | 3 mg |
| Vitamin B2 (riboflavin) | 3.4 mg |
| Niacin (niacinamide) | 20 mg |
| Vitamin B6 (pyridoxine hydrochloride) | 20 mg |
| Folic Acid | 1 mg |
| Vitamin B12 (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 for TriAdvance
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 B12 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.
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 suffcient 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.
TriAdvance Dosage and Administration
Usual dosage is one tablet daily, or as prescribed by a physician.
How is TriAdvance 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 - 90 Tablet Bottle Label
NDC 13811-529-90
Rx Only
TriAdvance
Prenatal Vitamin Tablets
90 TABLETS
TRIGEN
LABORATORIES
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 09/10/2010 | ||
| Labeler - TRIGEN Laboratories, Inc. (830479668) |
No comments:
Post a Comment