TL GARD RX- folic acid, pyridoxine hydrochloride, and cyanocobalamin tablet, film coated 
Trigen Laboratories, LLC

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TL Gard Rx
Tablets

Rx Only

DESCRIPTION

TL Gard Rx are round, light pink, speckled, film-coated tablets debossed "TL015" and intended for oral administration.

Supplement Facts
Servings per Bottle: 100
Serving Size: 1 tablet
Each tablet contains		 % DV for Adults Only
Folic Acid2.2 mg550%
Vitamin B6 (pyridoxine HCl)25 mg1250%
Vitamin B12 (cyanocobalamin)1 mg167%

Inactive Ingredients:
Microcrystalline Cellulose, Di Cal Phosphate, TriPotassium Citrate, Citric Acid, Sodium Carboxymethyl Cellulose, Stearic Acid, Silicon Dioxide, Dextrin, Dextrose (corn), Lecithin, Sodium Citrate.

INDICATIONS AND USAGE

TL Gard Rx tablets are indicated for nutritional support and folic acid supplementation.

CONTRAINDICATIONS

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

THIS PRODUCT CONTAINS SOY.

PRECAUTIONS

Folic acid when taken in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

Adults - one tablet daily or as prescribed by a physician.

HOW SUPPLIED

TL Gard Rx tablets are available in bottles of 100 tablets.

Product Code: 13811-527-01

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 light and moisture.

Dispense in a tight container with a child-resistant closure.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

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.

KEEP OUT OF REACH OF CHILDREN.

Rx Only

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 04/13

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-527-01
Rx Only

TL Gard Rx
Tablets

DIETARY SUPPLEMENT

Rx Only

TRIGEN
LABORATORIES

100 Tablets

Principal Display Panel - 100 Tablet Bottle Label
TL GARD RX 
folic acid, pyridoxine hydrochloride, and cyanocobalamin tablet, film coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-527
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid2.2 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride25 mg
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin1 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline (UNII: OP1R32D61U)  
Calcium Phosphate, Dibasic, Anhydrous (UNII: L11K75P92J)  
potassium citrate anhydrous (UNII: 86R1NVR0HW)  
citric acid monohydrate (UNII: 2968PHW8QP)  
carboxymethylcellulose sodium (UNII: K679OBS311)  
stearic acid (UNII: 4ELV7Z65AP)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
icodextrin (UNII: 2NX48Z0A9G)  
dextrose (UNII: IY9XDZ35W2)  
sodium citrate (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-527-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT06/01/201001/31/2020
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)12 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 11/2019
Document Id: 718343f0-9abc-41d0-badc-b9658031df59
Set id: 737ba5b9-8aec-4593-a93a-d3d0b4a5c529
Version: 3
Effective Time: 20191107
 
Trigen Laboratories, LLC