TL G-FOL OS- folic acid, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, and boro

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB), cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838), boron citrate (UNII: S043P4DV22) (boron - UNII:N9E3X5056Q)

Available from:

Trigen Laboratories, Inc.

INN (International Name):

folic acid

Composition:

folic acid 1.1 mg

Administration route:

ORAL

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

Product summary:

TL G-Fol OS tablets for oral administration are packaged in bottles of 60 tablets. Product Code: 13811-504-60

Authorization status:

Dietary Supplement

Summary of Product characteristics

TL G-FOL OS- FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN,
CALCIUM CARBONATE,
CHOLECALCIFEROL, MAGNESIUM OXIDE, AND BORON CITRATE TABLET, COATED
TRIGEN LABORATORIES, INC.
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TL G-FOL OS
TABLETS
R 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 ACID
1.1 MG
250%
VITAMIN B (pyridoxine HCl)
12.5 MG
625%
VITAMIN B
(cyanocobalamin)
250 MCG
15%
CALCIUM (calcium carbonate)
500 MG
15%
VITAMIN D (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 B
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.
X
6
12
3
12
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