Indications and uses
TL Folate is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
TL Folate Tablets
- Manufacturer
- Trigen Laboratories, LLC
- Effective date
- 2014-11-18
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:34:31
Label at a glance#
ProductTL-Folate
Active ingredientlevomefolic 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, cupric oxide
Label structure14 sections
Dosage and administration
One tablet daily or as directed by a physician.
Contacts and useful links#
Websitewww.trigenlab.com
www.trigenlab.com
www.trigenlab.comLabel contents#
Full prescribing information#
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.
WARNINGS SECTION
| 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.
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
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].
WARNINGS SECTION
KEEP OUT OF REACH OF CHILDREN
HEALTH CLAIM SECTION
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, LLC., Sayreville, NJ 08872www.trigenlab.com
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
Rx Only
13811- 574-10
TL Folate
100 Tablets
TRIGEN
LABORATORIES
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-574-10 | EA - Each | 13811-574 | 428311c2-2656-43ca-950d-091466312e49 | 1 | 2014-12-01 |
| 13811-574-50 | EA - Each | 13811-574 | 79f6c5c5-9785-43c8-8268-d682790fd824 | 1 | 2014-12-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| .BETA.-CAROTENE | ACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| ascorbic acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| biotin | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| calcium carbonate | ACTIVE INGREDIENT | H0G9379FGK | 1 | |
| calcium pantothenate | ACTIVE INGREDIENT | 568ET80C3D | 1 | |
| cholecalciferol | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| cupric oxide | ACTIVE INGREDIENT | V1XJQ704R4 | 1 | |
| cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| ferrous fumarate | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| folic acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| levomefolic acid | ACTIVE INGREDIENT | 8S95DH25XC | 1 | |
| magnesium oxide | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| niacinamide | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| potassium iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| pyridoxine hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| thiamine mononitrate | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| zinc oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .alpha.-tocopherol, dl- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| .BETA.-CAROTENE | ACTIVE MOIETY | 01YAE03M7J | 1 | |
| ascorbic acid | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| biotin | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| calcium cation | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| cholecalciferol | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| cupric cation | ACTIVE MOIETY | 8CBV67279L | 1 | |
| cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| ferrous cation | ACTIVE MOIETY | GW89581OWR | 1 | |
| folic acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| iodide ion | ACTIVE MOIETY | 09G4I6V86Q | 1 | |
| levomefolic acid | ACTIVE MOIETY | 8S95DH25XC | 1 | |
| magnesium cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| niacinamide | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| riboflavin | ACTIVE MOIETY | TLM2976OFR | 1 | |
| thiamine ion | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| zinc cation | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| ascorbyl palmitate | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- 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
- levomefolic acid
- folic acid
- .BETA.-CAROTENE
- ascorbic acid
- cholecalciferol
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- .alpha.-tocopherol, dl-
- thiamine mononitrate
- thiamine ion
- thiamine
- riboflavin
- niacinamide
- pyridoxine hydrochloride
- pyridoxine
- cyanocobalamin
- biotin
- calcium pantothenate
- calcium cation
- calcium carbonate
- ferrous fumarate
- ferrous cation
- potassium iodide
- iodide ion
- magnesium oxide
- magnesium cation
- zinc oxide
- zinc cation
- cupric oxide
- cupric cation
- cellulose, microcrystalline
- hypromelloses
- titanium dioxide
- polyvinyl alcohol
- polyethylene glycols
- talc
- starch, corn
- croscarmellose sodium
- silicon dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13811-574 | 13811-574-10, 13811-574-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| talc | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / OPHTHALMIC | 1.4 %w/w | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | IMPLANT / INTRAVITREAL | 0.12 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| ascorbyl palmitate | ASCORBYL PALMITATE | QN83US2B0N | TABLET / ORAL | 7.14 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| talc | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| starch, corn | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| talc | TALC | 7SEV7J4R1U | PELLET / ORAL | 69 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET / RECTAL | 32.4 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | CAPSULE / ORAL | 1.67 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| croscarmellose sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.