TRINATAL GT- iron, biotin, pantothenic acid, calcium carbonate, cupric oxide, zinc oxide, folic acid, beta carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, magnesium 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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Trinatal GT
Prenatal Vitamin and
Mineral Supplement
DESCRIPTION
Trinatal GT is a purple, oval, oil and water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet is debossed "TL614".
| Each tablet contains: | |
| Elemental Iron (carbonyl iron) | 90 mg |
| Biotin | 30 mcg |
| Pantothenic Acid | 6 mg |
| Calcium (calcium carbonate) | 200 mg |
| Copper (cupric oxide) | 2 mg |
| Zinc (zinc oxide) | 15 mg |
| Folic Acid | 1 mg |
| Vitamin A (beta carotene) | 2700 IU |
| Vitamin D 3(cholecalciferol) | 400 IU |
| Vitamin E (dl-alpha tocopheryl acetate) | 10 IU |
| Vitamin C (ascorbic acid) | 120 mg |
| Vitamin B 1(thiamine mononitrate) | 3 mg |
| Vitamin B 2(riboflavin) | 3.4 mg |
| Vitamin B 6(pyridoxine HCl) | 20 mg |
| Vitamin B 12(cyanocobalamin) | 12 mcg |
| Niacinamide | 20 mg |
| Magnesium (magnesium oxide) | 30 mg |
| Docusate Sodium | 50 mg |
Inactive Ingredients
Microcrystalline Cellulose, Tripotassium Citrate, Citric Acid, Croscarmellose Sodium, Povidone K30, Hypromellose, Acacia, Magnesium Stearate, Stearic Acid, Fumed Silica, Titanium Dioxide, Carmine, Talc, Polyethylene Glycol, Ethyl Cellulose, Black Iron Oxide, Polysorbate 80, Mineral Oil, Hydroxypropyl Cellulose.
INDICATIONS AND USAGE
Trinatal GT 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. Trinatal GT 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
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 remain progressive.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
HOW SUPPLIED
Trinatal GT is supplied as child-resistant blister cards containing 90 tablets (9 blister cards of 10 tablets per card).
NDC 13811-614-90
STORAGE
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86° F).
[See USP Controlled Room Temperature].
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. 03/11
| TRINATAL GT
iron, biotin, pantothenic acid, calcium carbonate, cupric oxide, zinc oxide, folic acid, beta carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, magnesium oxide, and docusate sodium tablet |
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| Labeler - Trigen Laboratories, LLC (830479668) |