TL G-Fol OS by Trigen Laboratories, Inc. TL G-Fol OS Tablets

TL G-Fol OS by

Drug Labeling and Warnings

TL G-Fol OS by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TL G-FOL OS- folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, and boron citrate tablet, coated 
Trigen Laboratories, LLC

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TL G-Fol OS
Tablets

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 Facts
Servings per Bottle: 30
Serving Size: 2 Tablets
Each Tablet contains:
%DV for Adults Only
Folic Acid1.1 mg250%
Vitamin B6 (pyridoxine HCl)12.5 mg625%
Vitamin B12 (cyanocobalamin)250 mcg15%
Calcium (calcium carbonate)500 mg15%
Vitamin D3 (cholecalciferol)300 IU 15%
Magnesium (magnesium oxide)100 mg694%
Boron (boron citrate)1.5 mg67%

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.

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

Principal Display Panel - 60 Tablet Bottle Label
TL G-FOL OS 
folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, and boron citrate tablet, coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) folic acid1.1 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride12.5 mg
cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) cyanocobalamin250 ug
calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) calcium carbonate500 mg
cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol300 [iU]
magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) magnesium oxide100 mg
boron citrate (UNII: S043P4DV22) (boron - UNII:N9E3X5056Q) boron citrate1.5 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline (UNII: OP1R32D61U)  
hypromelloses (UNII: 3NXW29V3WO)  
titanium dioxide (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
triacetin (UNII: XHX3C3X673)  
talc (UNII: 7SEV7J4R1U)  
FD&C blue No. 1 (UNII: H3R47K3TBD)  
aluminum oxide (UNII: LMI26O6933)  
FD&C blue No. 2 (UNII: L06K8R7DQK)  
FD&C yellow No. 6 (UNII: H77VEI93A8)  
potassium citrate anhydrous (UNII: 86R1NVR0HW)  
croscarmellose sodium (UNII: M28OL1HH48)  
citric acid monohydrate (UNII: 2968PHW8QP)  
magnesium stearate (UNII: 70097M6I30)  
povidone K30 (UNII: U725QWY32X)  
acacia (UNII: 5C5403N26O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-504-6060 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT03/01/201010/31/2019
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)22 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 11/2019
 
Trigen Laboratories, LLC