Trinatal GT

Generic Name: prenatal vitamin and mineral supplement

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Trinatal GT
Prenatal Vitamin and
Mineral Supplement

Trinatal GT Description

Trinatal GT is a purple, oval, oil and water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. Each tablet is debossed "TL614".

Each tablet contains:
Elemental Iron (carbonyl iron) 90 mg
Biotin 30 mcg
Pantothenic Acid 6 mg
Calcium (calcium carbonate) 200 mg
Copper (cupric oxide) 2 mg
Zinc (zinc oxide) 15 mg
Folic Acid 1 mg
Vitamin A (beta carotene) 2700 IU
Vitamin D3 (cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate) 10 IU
Vitamin C (ascorbic acid) 120 mg
Vitamin B1 (thiamine mononitrate) 3 mg
Vitamin B2 (riboflavin) 3.4 mg
Vitamin B6 (pyridoxine HCl) 20 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Niacinamide 20 mg
Magnesium (magnesium oxide) 30 mg
Docusate Sodium 50 mg

Inactive Ingredients

Microcrystalline Cellulose, Tripotassium Citrate, Citric Acid, Croscarmellose Sodium, Povidone K30, Hypromellose, Acacia, Magnesium Stearate, Stearic Acid, Fumed Silica, Titanium Dioxide, Carmine, Talc, Polyethylene Glycol, Ethyl Cellulose, Black Iron Oxide, Polysorbate 80, Mineral Oil, Hydroxypropyl Cellulose.

Indications and Usage for Trinatal GT

Trinatal GT is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Trinatal GT can also be beneficial in improving the nutritional status of women prior to conception.

Contraindications

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

Warnings

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 alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions

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

Trinatal GT Dosage and Administration

One tablet daily or as prescribed by a physician.

How is Trinatal GT Supplied

Trinatal GT is supplied as child-resistant blister cards containing 90 tablets (9 blister cards of 10 tablets per card).

NDC 13811-614-90

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86° F).

[See USP Controlled Room Temperature].

Call your doctor about side effects. You may report side effects by calling

888 9 TRIGEN (888-987-4436).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

All prescriptions using this product shall be pursuant to state 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. 03/11

PRINCIPAL DISPLAY PANEL - 90 Tablet Carton

NDC 13811-614-90
Rx Only

Trinatal GT

Prenatal Vitamin and
Mineral Supplement

90 Unit-Dose Tablets

TRIGEN
LABORATORIES

Trinatal GT 
iron, biotin, pantothenic acid, calcium carbonate, cupric oxide, zinc oxide, folic acid, beta carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, niacinamide, magnesium oxide, and docusate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-614
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iron (Iron) Iron 90 mg
Biotin (Biotin) Biotin 30 ug
Pantothenic Acid (Pantothenic Acid) Pantothenic Acid 6 mg
Calcium Carbonate (Calcium Cation) Calcium Carbonate 200 mg
Cupric Oxide (Cupric Cation) Cupric Oxide 2 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 15 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Beta Carotene (Beta Carotene) Beta Carotene 2700 [iU]
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
.Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol Acetate, DL-) .Alpha.-Tocopherol Acetate, DL- 10 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 120 mg
Thiamine Mononitrate (Thiamine) Thiamine Mononitrate 3 mg
Riboflavin (Riboflavin) Riboflavin 3.4 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 20 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Niacinamide (Niacinamide) Niacinamide 20 mg
Magnesium Oxide (Magnesium Oxide) Magnesium Oxide 30 mg
Docusate Sodium (Docusate) Docusate Sodium 50 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Potassium Citrate Anhydrous  
Citric Acid Monohydrate  
Croscarmellose Sodium  
Povidone K30  
Hypromelloses  
Acacia  
Magnesium Stearate  
Stearic Acid  
Silicon Dioxide  
Titanium Dioxide  
Cochineal  
Talc  
Polyethylene Glycols  
Ethylcelluloses  
Ferrosoferric Oxide  
Polysorbate 80  
Mineral Oil  
Hydroxypropyl Cellulose  
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code TL614
Contains         
Packaging
# Item Code Package Description
1 NDC:13811-614-90 9 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 07/05/2011
Labeler - TRIGEN Laboratories, Inc. (830479668)
Revised: 09/2011
 
TRIGEN Laboratories, Inc.
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