Taron BC (folic acid 1 mg ascorbic acid 120 mg calcium carbonate 400 mg iron 20 mg cholecalciferol 400 [iu] pyridoxine hydrochloride 25 mg) Dailymed
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IMPRINT: T569
SHAPE: oval
COLOR: white
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Description
Taron TM -Bc is a prescription prenatal multivitamin/mineral tablet with a high level of B6, along with two vitamin B6 tablets. TaronTM-Bc multivitamin/mineral prenatal tablets are white-coated, oval tablets with “T569” debossed on one side. Taron™-Bc vitamin B6 tablets are white, round tablets debossed “B6” on one side.
Supplement Facts Servings per Carton: 90Serving Size: 1 Tablet %DV Pregnant and Lactating Women Prenatal Tablet (T569)Amount Per Serving %Daily Value Folic Acid..... ....... 1 mg.....125% Vitamin C (ascorbic acid) ........ ....... 120 mg.....200% Calcium (calcium carbonate) ...... ....... 125 mg.....10% Iron (carbonyl iron) ........ ....... 20 mg.....111% Vitamin D3 (cholecalciferol) ......... ...... 400 IU.......100% Vitamin B6 (pyridoxine HCl)...... ...... 25 mg.......1000% Vitamin B6Tablet (B6)Amount Per Serving %Daily Value Vitamin B6 (pyridoxine HCl)...... ...... 25 mg.......1000%
Statement Of Identity Section
Inactive Ingredients (Prenatal tablet): Microcrystalline Cellulose, TriPotassium Citrate, Hypromellose, Citric Acid, Acacia, Titanium Dioxide, Povidone K30, Polyvinyl Alcohol, Croscarmellose Sodium, Polyethylene Glycol, Magnesium Stearate, Stearic Acid, Talc, Fumed Silica.
Inactive Ingredients (B6 tablet): Microcrystalline Cellulose, Di Cal Phosphate, Silicon Dioxide, Stearic Acid, Ethyl Vanillin.
Indications
Taron TM Bc is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers. Taron TM-Bc may be used in conjunction with a physician prescribed regimen to help minimize pregnancy related nausea and vomiting.
Contraindications
This product is contraindicated in patients with 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.
Precaution
General:
Folic acid, 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 hematologic 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. Folates therapy alone is inadequate for the treatment of B12 deficiency.
PATIENT INFORMATION
TaronTM 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 occured 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.
Dosage And Administration
Three (3) tablets per day: One (1) tablet every eight hours beginning with the multivitamin (white-coated, oval tablet debossed with “T569”) followed by the vitamin B6 tablets (white, round tablets debossed with “B6”).
How Supplied
TaronTM is supplied in child-resistant 6 buler cards. Each card contains 5 doses of one (1) multivitamin/mineral tablet asnd two (2) vitamin B6 tablets.
PRODUCT CODE 13811-569-30
Storage
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. Contact with moisture can discolor or erode tablets.
Precautions Section
Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).
KEEP THIS PRODUCT 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 equivalences.
Health Claim Section
Manufactured for: TRIGEN Laboratories, Inc., Sayreville, NJ 08872www.trigenlab.com
Rev. 06/13
Principal Display Panel - 30 Tablets/60 B Tablets Label
13811-569-30Rx Only
TaronTM - Bc Tablets
30 TABLETS/60 B6 TABLETS
TRIGEN LABORATORIES
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