TL Gard Rx
TL Gard Rx Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
- TL GARD RX DESCRIPTION
- TL GARD RX INDICATIONS AND USAGE
- TL GARD RX CONTRAINDICATIONS
- PRECAUTIONS
- TL GARD RX ADVERSE REACTIONS
- TL GARD RX DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
FULL PRESCRIBING INFORMATION
Rx Only
TL GARD RX 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 Acid | 2.2 mg | 550% |
| Vitamin B6 (pyridoxine HCl) | 25 mg | 1250% |
| Vitamin B12 (cyanocobalamin) | 1 mg | 167% |
Inactive Ingredients:
Microcrystalline Cellulose, Di Cal Phosphate, TriPotassium Citrate, Citric Acid, Sodium Carboxymethyl Cellulose, Stearic Acid, Silicon Dioxide, Dextrin, Dextrose (corn), Lecithin, Sodium Citrate.
TL GARD RX INDICATIONS AND USAGE
TL Gard Rx tablets are indicated for nutritional support and folic acid supplementation.
TL GARD RX 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.
TL GARD RX ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
TL GARD RX 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
TL Gard RxFolic Acid, pyridoxine Hydrochloride, and cyanocobalamin TABLET, FILM COATED
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