TL G-Fol OS description, usages, side effects, indications, overdosage, supplying and lots more!

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TL G-Fol OS

TRIGEN Laboratories, Inc.

TL G-Fol OS Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




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 OS

TL G-Fol OS

folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, and boron citrate TABLET, COATED

Product Information

Product Type Dietary supplement Item Code (Source) NDC:13811-504
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FOLIC ACID FOLIC ACID 1.1 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 12.5 mg
Cyanocobalamin CYANOCOBALAMIN 250 ug
CALCIUM CARBONATE 500 mg
CHOLECALCIFEROL CHOLECALCIFEROL 300 [iU]
magnesium oxide 100 mg
BORON CITRATE boron 1.5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
HYPROMELLOSES
titanium dioxide
POLYVINYL ALCOHOL
triacetin
talc
FD&C BLUE NO. 1
ALUMINUM OXIDE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
Potassium Citrate Anhydrous
CROSCARMELLOSE SODIUM
CITRIC ACID MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
ACACIA

Product Characteristics

Color Size Imprint Code Shape
BLUE 22 mm T504 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-504-60 60 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-03-01


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