TL G-Fol OS Tablets

Manufacturer
Trigen Laboratories, Inc.
Effective date
2013-06-18
Label type
DIETARY SUPPLEMENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:31

Label at a glance#

ProductTL G-Fol OS
Active ingredientfolic acid, pyridoxine Hydrochloride, cyanocobalamin, calcium carbonate, cholecalciferol, magnesium oxide, boron citrate
Label structure14 sections

Dosage and administration

Two tablets daily, or as prescribed by a physician.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

Rx Only

DESCRIPTION

STATEMENT OF IDENTITY SECTION

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

STATEMENT OF IDENTITY SECTION

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

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

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

WARNING

WARNINGS SECTION

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

PRECAUTIONS SECTION

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

HEALTH CLAIM SECTION

Folic Acid

HEALTH CLAIM SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Two tablets daily, or as prescribed by a physician.

HOW SUPPLIED

HEALTH CLAIM SECTION

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

Product Code: 13811-504-60

STORAGE

SAFE HANDLING WARNING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

13811-504-60
Rx Only

TL G-Fol OS
Tablets

60 TABLETS

TRIGEN
LABORATORIES

Principal Display Panel - 60 Tablet Bottle Label
Principal Display Panel - 60 Tablet Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-504-60EA - Each13811-50445482dae-2451-46f6-b51f-61fa6ee7c15812013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
boron citrateACTIVE INGREDIENTS043P4DV221
calcium carbonateACTIVE INGREDIENTH0G9379FGK1
cholecalciferolACTIVE INGREDIENT1C6V77QF411
cyanocobalaminACTIVE INGREDIENTP6YC3EG2041
folic acidACTIVE INGREDIENT935E97BOY81
magnesium oxideACTIVE INGREDIENT3A3U0GI71G1
pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
boronACTIVE MOIETYN9E3X5056Q1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
acaciaINACTIVE INGREDIENT5C5403N26O1
aluminum oxideINACTIVE INGREDIENTLMI26O69331
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH481
FD&C blue No. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C blue No. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A81
hypromellosesINACTIVE INGREDIENT3NXW29V3WO1
magnesium stearateINACTIVE INGREDIENT70097M6I301
polyvinyl alcoholINACTIVE INGREDIENT532B59J9901
potassium citrate anhydrousINACTIVE INGREDIENT86R1NVR0HW1
povidone K30INACTIVE INGREDIENTU725QWY32X1
talcINACTIVE INGREDIENT7SEV7J4R1U1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
triacetinINACTIVE INGREDIENTXHX3C3X6731

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13811-50413811-504-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 453 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
povidone K30POVIDONE K30U725QWY32XLOZENGE / ORAL700 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
povidone K30POVIDONE K30U725QWY32XINSERT / VAGINAL147 mgExact identifier — unii candidate
40 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii candidate
27 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
povidone K30POVIDONE K30U725QWY32XCAPSULE / ORAL540 mgExact identifier — unii candidate
40 equally ranked IID candidates
povidone K30POVIDONE K30U725QWY32XCAPSULE, LIQUID FILLED / ORAL101 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION, EXTENDED RELEASE / ORAL0.12 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990SOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
17 equally ranked IID candidates
povidone K30POVIDONE K30U725QWY32XGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
40 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
acaciaACACIA5C5403N26OTABLET / BUCCAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673SUSPENSION / ORAL7 mgExact identifier — unii candidate
14 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
talcTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
talcTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
povidone K30POVIDONE K30U725QWY32XFILM / SUBLINGUAL7 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C blue No. 2FD&C BLUE NO. 2L06K8R7DQKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
triacetinTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii candidate
14 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
acaciaACACIA5C5403N26OTABLET, COATED / ORAL156 mgExact identifier — unii candidate
19 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
acaciaACACIA5C5403N26OCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
19 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990IMPLANT / INTRAVITREAL0.12 mgExact identifier — unii candidate
17 equally ranked IID candidates
FD&C yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
povidone K30POVIDONE K30U725QWY32XTABLET, ORALLY DISINTEGRATING / ORAL71 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
acaciaACACIA5C5403N26OSUSPENSION / ORAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
polyvinyl alcoholPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
17 equally ranked IID candidates
croscarmellose sodiumCROSCARMELLOSE SODIUMM28OL1HH48SUSPENSION / ORAL150 mgExact identifier — unii candidate
22 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDREMEDYREPACK INC.bda4687e-929a-434d-ab59-909cf2ed73a22026-09-11Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDREMEDYREPACK INC.368b69a8-a021-47e3-a6d7-e3497d7363b12026-09-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDRising Pharma Holdings, Inc.0baa10dd-6d1d-4946-8236-566451132da32026-07-24Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDNorthwind Health Company, LLC03b0aee4-804a-de63-e063-6394a90a66352026-07-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDUnit Dose Solutions, Inc.54db8b21-87b9-5e0c-e063-6394a90ae8ea2026-06-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
VitramynFOLIC ACIDPureTek Corporationc8af7616-5178-6df0-e053-2a95a90a334d2026-06-18Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
FOLIC ACIDFOLIC ACIDCoupler LLC544e394d-3555-8ab1-e063-6394a90ade002026-06-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDMajor Pharmaceuticals7778ac96-7817-455a-a177-22ecb276c67f2026-05-26Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDQUAGEN PHARMACEUTICALS LLC354366ea-3702-4706-9fc0-0244b7278bd82026-05-20Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC624469a1-ded9-453a-973e-c5a2f0602bb02026-05-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDCardinal Health 107, LLC6dd867fe-597e-4915-8baf-98a605bf93242026-05-06Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDPreferred Pharmaceuticals Inc.b4c3a754-64cd-499a-a32f-a6e935c413552026-04-22Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDXGen Pharmaceuticals DJB, Inc.c5b2b84d-9f5e-4b81-ba10-9f2854e5dce92026-01-21Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC40ab3c91-5a5b-fa1d-e063-6394a90a74542025-12-10Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDAmerican Health Packagingfc6dc1e1-f63e-4239-a1eb-67525569f68c2025-11-13Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack4889d474-bd72-46ba-81d6-5511d8a85abb2025-11-04Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID
Folic AcidFOLIC ACIDBryant Ranch Prepack41914ac8-f4f5-4d70-b9f2-9f88c59d67a62025-10-29Warnings, Adverse reactionsName fallback
generic name: FOLIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.