TL-Folate by Trigen Laboratories, LLC TL Folate Tablets
TL-Folate by
Drug Labeling and Warnings
TL-Folate by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
TL-FOLATE- levomefolic acid, folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide, and cupric oxide tablet, coated
Trigen Laboratories, LLC
----------
TL Folate Tablets
DESCRIPTION
TL Folate is a prescription prenatal/postnatal multivitamin/mineral tablet. TL Folate are oval, white tablets with "TL574"debossed on one side.
| Supplement Facts Servings per Bottle: 100 |
||
|---|---|---|
| Serving Size: 1 Tablet Each Tablet contains | %DV for Pregnant and Lactating Women | |
| Folate | 1 mg | 125% |
| (L-methylfolate, or 6(S)-5-MTHF 500 mcg) (folic acid, USP 500 mcg) | ||
| Vitamin A (beta-carotene) | 4000 IU | 50% |
| Vitamin C (ascorbic acid) | 80 mg | 133% |
| Vitamin D3 (cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-alpha tocopherol acetate) | 30 IU | 100% |
| Vitamin B1 (thiamine mononitrate) | 3 mg | 176% |
| Vitamin B2 (riboflavin) | 3.4 mg | 170% |
| Vitamin B3 (niacinamide) | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl) | 20 mg | 800% |
| Vitamin B12 | 12 mcg | 150% |
| Biotin | 300 mcg | 100% |
| Pantothenic acid (calcium pantothenate) | 6 mg | 60% |
| Calcium (calcium carbonate) | 120 mg | 9% |
| Iron (ferrous fumarate) | 27 mg | 150% |
| Iodine (potassium iodide) | 150 mcg | 100% |
| Magnesium (magnesium oxide) | 90 mg | 20% |
| Zinc (zinc oxide) | 15 mg | 100% |
| Copper (copper oxide) | 2 mg | 100% |
OTHER INGREDIENTS: Microcrystalline Cellulose, Coating (Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol, Talc), Pregelatinized Starch Croscarmellose Sodium, Fumed Silica, Silicon Dioxide, Ascorbyl Palmitate, Magnesium Stearate, Stearic Acid.
INDICATIONS AND USAGE
TL Folate is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
| 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
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
PATIENT INFORMATION
TL Folate is a prescription vitamin for use only under the direction and supervision of a licensed physician.
INTERACTIONS
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Drugs which may interact with folate include:
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the levels of this AED in the blood and allowing breakthrough seizures to occur.
- Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
- Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
- Colestipol: Reduces folic acid absorption and reduces serum folate levels.
- Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
- Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
- Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
- Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
- Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
- Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
- Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
- Smoking and alcohol: Reduced serum folate levels have been noted.
- Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
- Metformin treatment in patients with type 2 diabetes decreases serum folate.
- Warfarin can produce significant impairment in folate status after a 6 - month therapy.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates - including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.
Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.
HOW SUPPLIED
TL Folate is dispensed in bottles of 100 and 500 tablets.
PRODUCT CODE : 13811-574-10
PRODUCT CODE : 13811-574-50
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].
| TL-FOLATE
levomefolic acid, folic acid, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, zinc oxide, and cupric oxide tablet, coated |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Supplement Facts | ||
| Serving Size : | Serving per Container : | |
| Amount Per Serving | % Daily Value | |
|---|---|---|
| color | ||
| imprint | ||
| scoring | 1 | |
| shape | ||
| size (solid drugs) | 20 mm | |
| Labeler - Trigen Laboratories, LLC (830479668) |