Trinatal Ultra by Trigen Laboratories, Inc. Trinatal Ultra Tablets
Trinatal Ultra by
Drug Labeling and Warnings
Trinatal Ultra by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
TRINATAL ULTRA- vitamin a palmitate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium citrate, iron pentacarbonyl, potassium iodide, zinc oxide, cupric oxide, and docusate sodium tablet
Trigen Laboratories, LLC
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Trinatal Ultra
Tablets
DESCRIPTION
Trinatal Ultra is a prescription prenatal multivitamin/multimineral tablet which contains calcium citrate and carbonyl iron. Each dye-free, oil-and-water soluble, white tablet is debossed "TL615".
| Supplement Facts Servings per Bottle: 100 |
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| Serving Size: 1 Tablet Each Tablet contains | %DV for Pregnant and Lactating Women |
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| Vitamin A (vitamin A palmitate and beta carotene) | 2700 IU* | 34% |
| Vitamin C (ascorbic acid) | 120 mg | 200% |
| Vitamin D3 (cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-alpha-tocopheryl acetate) | 30 IU | 100% |
| Vitamin B1 (thiamine mononitrate) | 3 mg | 176% |
| Vitamin B2 (riboflavin) | 3.4 mg | 170% |
| Niacinamide | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl) | 20 mg | 800% |
| Folic Acid | 1 mg | 125% |
| Vitamin B12 (cyanocobalamin) | 12 mcg | 150% |
| Calcium (calcium citrate) | 200 mg | 15% |
| Iron, Elemental (carbonyl iron) | 90 mg | 500% |
| Iodine (potassium iodide) | 150 mcg | 100% |
| Zinc (zinc oxide) | 25 mg | 167% |
| Copper (cupric oxide) | 2 mg | 100% |
| Docusate Sodium | 50 mg | 3% |
INDICATIONS AND USAGE
Trinatal Ultra 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 non-lactating mothers. Trinatal Ultra 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.
| 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 dose.
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]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
| TRINATAL ULTRA
vitamin a palmitate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium citrate, iron pentacarbonyl, potassium iodide, zinc oxide, cupric oxide, and docusate sodium tablet |
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| Supplement Facts | ||
| Serving Size : | Serving per Container : | |
| Amount Per Serving | % Daily Value | |
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| color | ||
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| scoring | 1 | |
| shape | ||
| size (solid drugs) | 22 mm | |
| Labeler - Trigen Laboratories, LLC (830479668) |