TL G-Fol OS
TL G-Fol OS Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
- TL G-FOL OS DESCRIPTION
- INDICATIONS
- TL G-FOL OS CONTRAINDICATIONS
- WARNING
- PRECAUTION
- TL G-FOL OS ADVERSE REACTIONS
- TL G-FOL OS DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
Rx Only
TL G-FOL OS 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 Facts Servings per Bottle: 30 |
||
|---|---|---|
| Serving Size: 2 Tablets Each 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.
TL G-FOL OS 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.
TL G-FOL OS ADVERSE REACTIONS
Folic Acid
Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
TL G-FOL OS 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.
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. 04/13
PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
13811-504-60
Rx Only
TL G-Fol OS
Tablets
60 TABLETS
TRIGEN
LABORATORIES
TL G-Fol OSfolic acid, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, and boron citrate TABLET, COATED
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