Trinatal Rx 1
Trinatal Rx 1 Prenatal Multivitamin/Mineral Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
- TRINATAL RX 1 DESCRIPTION
- Inactive Ingredients
- INDICATIONS
- TRINATAL RX 1 CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- TRINATAL RX 1 ADVERSE REACTIONS
- RECOMMENDED USE
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
Rx Only
TRINATAL RX 1 DESCRIPTION
Trinatal Rx 1 is an oval shaped, white film-coated tablet debossed "TL388" that provides 12 vitamins and 5 minerals to supplement the diet during pregnancy or lactation.
| Supplement Facts Servings per Bottle: 100 |
||
|---|---|---|
| Serving Size: 1 Tablet Each Tablet contains |
%DV for Pregnant and Lactating Women |
|
| Vitamin A (acetate 3600 IU & beta carotene 400 IU) | 4000 IU | 50% |
| Vitamin D3 (cholecalciferol) | 400 IU | 100% |
| Vitamin E (di-alpha-tocopheryl acetate) | 15 IU | 50% |
| Vitamin C (ascorbic acid) | 80 mg | 133% |
| Folic Acid | 1 mg | 125% |
| Vitamin B1 (thiamine mononitrate) | 1.5 mg | 88% |
| Vitamin B2 (riboflavin) | 1.6 mg | 80% |
| Niacinamide | 17 mg | 85% |
| Vitamin B6 (pyridoxine HCl) | 4 mg | 160% |
| Vitamin B12 (cyanocobalamin) | 2.5 mcg | 31% |
| Biotin | 30 mcg | 10% |
| Pantothenic Acid | 7 mg | 70% |
| Calcium (calcium carbonate) | 200 mg | 15% |
| Iron (ferrous fumarate) | 60 mg | 333% |
| Magnesium (magnesium oxide) | 100 mg | 22% |
| Copper (cupric oxide) | 3 mg | 150% |
| Zinc (zinc oxide) | 25 mg | 167% |
Inactive Ingredients
Microcrystalline Cellulose, Hypromellose, TriPotassium Citrate, Titanium Dioxide, Polyvinyl Alcohol, Citric Acid, Croscarmellose Sodium, Povidone K30, Acacia, Magnesium Stearate, Stearic Acid, Polyethylene Glycol, Fumed Silica, Talc.
INDICATIONS
Trinatal Rx 1 tablets help assure an adequate intake of the vitamins and minerals listed. Folic acid helps prevent the development of megaloblastic anemia during pregnancy.
TRINATAL RX 1 CONTRAINDICATIONS
Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson's disease.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
| 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
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. 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 RX 1 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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
RECOMMENDED USE
Take One (1) tablet daily or as prescribed by a physician.
HOW SUPPLIED
Trinatal Rx 1 is supplied in bottles of 100 tablets.
Product Code: 13811-007-10
STORAGE
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
KEEP OUT OF THE REACH OF CHILDREN.
Rx Only
All prescriptions using this product shall be pursuant to 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
13811-007-10
Rx Only
100 Tablets
Trinatal Rx 1
(one tablet daily)
Prenatal Multivitamin/Multimineral Tablet
TRIGEN
LABORATORIES
Trinatal Rx 1acetate ion, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine Hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, magnesium oxide, ferrous fumarate, cupric oxide, and zinc oxide TABLET, FILM COATED
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