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TL G-Fol OS (folic acid 1.1 mg pyridoxine hydrochloride 12.5 mg cyanocobalamin 250 ug calcium carbonate 500 mg cholecalciferol 300 [iu] magnesium oxide 100 mg boron citrate 1.5 mg) Dailymed

  1. Dietary Supplement
  2. Archived
    • May Be Discontinued
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  3. Trigen Laboratories, LLC

Generic: folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, and boron citrate

TL G-Fol OS tablet, coated - (folic acid 1.1 mg pyridoxine hydrochloride 12.5 mg cyanocobalamin 250 ug calcium carbonate 500 mg cholecalciferol 300 [iu] magnesium oxide 100 mg boron citrate 1.5 mg) image

IMPRINT: T504     SHAPE: oval
    COLOR: blue

  1. FDA Adverse Reactions

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Health Claim Section


Rx Only

Description


TL G-Fol OS is an oval, blue coated tablet, debossed "T504". It is a prescription prenatal vitamin with other vitamins and minerals for nutritional supplementation.
Supplement FactsServings per Bottle: 30
Serving Size: 2 TabletsEach Tablet contains: %DV for Adults Only
Folic Acid 1.1 mg 250%
Vitamin B6 (pyridoxine HCl) 12.5 mg 625%
Vitamin B12 (cyanocobalamin) 250 mcg 15%
Calcium (calcium carbonate) 500 mg 15%
Vitamin D3 (cholecalciferol) 300 IU 15%
Magnesium (magnesium oxide) 100 mg 694%
Boron (boron citrate) 1.5 mg 67%

INACTIVE INGREDIENTS


Microcrystalline cellulose, coating (hypromellose, titanium dioxide, polyvinyl alcohol, triacetin, talc, FD&C blue #1 lake, FD&C blue #2 lake, FD&C yellow #6 lake), tripotassium citrate, croscarmellose sodium, citric acid, acacia, magnesium stearate, povidone K30*, fumed silica.

Indications


The ingredients in TL G-Fol OS tablets may decrease your risk of developing osteoporosis-a serious condition in which your bones weaken and become brittle, increasing your risk for painful fractures.

Contraindications


This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warning


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.

Precaution


Folic acid in doses above 0.8 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions


Folic Acid


Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Dosage And Administration


Two tablets daily, or as prescribed by a physician.

How Supplied


TL G-Fol OS tablets for oral administration are packaged in bottles of 60 tablets.

Product Code: 13811-504-60

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. Avoid freezing.

Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.

Health Claim Section


Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

Safe Handling Warning Section


KEEP OUT OF THE REACH OF CHILDREN.

Health Claim Section


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. 04/13

Principal Display Panel - 60 Tablet Bottle Label


13811-504-60 Rx Only

TL G-Fol OS Tablets

60 TABLETS

TRIGEN LABORATORIES

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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