Trinatal Ultra
Trinatal Ultra Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
- TRINATAL ULTRA DESCRIPTION
- TRINATAL ULTRA INDICATIONS AND USAGE
- TRINATAL ULTRA CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- TRINATAL ULTRA ADVERSE REACTIONS
- TRINATAL ULTRA DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
Rx Only
TRINATAL ULTRA 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 |
||
|---|---|---|
| Serving Size: 1 Tablet Each Tablet contains |
%DV for Pregnant and Lactating Women |
|
| 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% |
Inactive Ingredients
Microcrystalline Cellulose, TriPotassium Citrate, Croscarmellose Sodium, Magnesium Stearate, Acacia, Citric Acid, Povidone K30, Fumed Silica, Stearic Acid, Hypromellose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc.
TRINATAL ULTRA 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.
TRINATAL ULTRA 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.
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.
TRINATAL ULTRA 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.
TRINATAL ULTRA DOSAGE AND ADMINISTRATION
Usual dosage is one (1) tablet daily or as prescribed by a physician.
HOW SUPPLIED
Trinatal Ultra is supplied in bottles of 100 tablets.
PRODUCT CODE 13811-615-10
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).
KEEP OUT OF 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. 05/13
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
13811-615-10
Rx Only
Trinatal Ultra
Tablets
100 Tablets
TRIGEN
LABORATORIES
Trinatal UltraVitamin 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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