TriAdvance

Generic Name: prenatal vitamins
Dosage Form: tablet

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.

TriAdvance
Prenatal Vitamin Tablets

Rx Only

TriAdvance Description

TriAdvance is a prescription prenatal multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron. It is a yellow-speckled tablet debossed "TL020".

Each tablet for oral administration contains:

Vitamin A (beta-carotene) 2700 I.U.
Vitamin C (ascorbic acid) 120 mg
Vitamin D3 (cholecalciferol) 400 I.U.
Vitamin E (dl-alpha-tocopheryl acetate) 30 I.U.
Vitamin B1 (thiamine mononitrate) 3 mg
Vitamin B2 (riboflavin) 3.4 mg
Niacin (niacinamide) 20 mg
Vitamin B6 (pyridoxine hydrochloride) 20 mg
Folic Acid 1 mg
Vitamin B12 (cyanocobalamin) 12 mcg
Calcium (calcium carbonate) 200 mg
Iron (carbonyl iron) 90 mg
Magnesium (magnesium oxide) 30 mg
Zinc (zinc oxide) 25 mg
Copper (cupric oxide) 2 mg
Docusate Sodium 50 mg

Inactive Ingredients: Microcrystalline Cellulose, TriPotassium Citrate, Gum Arabic, Fumed Silica, Croscarmellose Sodium, Citric Acid, Povidone K30, Sodium Carboxymethyl Cellulose, Magnesium Stearate, Stearic Acid, Dextrin, Dextrose, Lecithin, Sodium Citrate.

Indications and Usage for TriAdvance

TriAdvance 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. TriAdvance 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

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.

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.

Precautions

General

The calcium content should be considered before prescribing for patients with kidney stones. Do not exceed the recommended dosage.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in suffcient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy.

Adverse Reactions

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

TriAdvance Dosage and Administration

Usual dosage is one tablet daily, or as prescribed by a physician.

How is TriAdvance Supplied

TriAdvance is supplied in bottles of 90 tablets.

NDC 13811-529-90

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30° C (59°- 86°F). [See USP Controlled Room Temperature].

Note that contact with moisture may produce surface discoloration or erosion of the tablet.

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. 05/11

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

NDC 13811-529-90
Rx Only

TriAdvance

Prenatal Vitamin Tablets

90 TABLETS

TRIGEN
LABORATORIES

TriAdvance 
beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide, and docusate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-529
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Beta Carotene (Beta Carotene) Beta Carotene 2700 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 120 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
.Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol Acetate, DL-) .Alpha.-Tocopherol Acetate, DL- 30 [iU]
Thiamine Mononitrate (Thiamine) Thiamine Mononitrate 3 mg
Riboflavin (Riboflavin) Riboflavin 3.4 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 20 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Calcium Carbonate (Calcium Cation) Calcium Carbonate 200 mg
Iron (Iron) Iron 90 mg
Magnesium Oxide (Magnesium Oxide) Magnesium Oxide 30 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Oxide (Cupric Cation) Cupric Oxide 2 mg
Docusate Sodium (Docusate) Docusate Sodium 50 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Potassium Citrate Anhydrous  
Acacia  
Silicon Dioxide  
Croscarmellose Sodium  
Citric Acid Monohydrate  
Povidone K30  
Carboxymethylcellulose Sodium  
Magnesium Stearate  
Stearic Acid  
Icodextrin  
Dextrose  
Sodium Citrate  
Product Characteristics
Color YELLOW (speckled) Score no score
Shape OVAL (caplet) Size 19mm
Flavor Imprint Code TL020
Contains         
Packaging
# Item Code Package Description
1 NDC:13811-529-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 09/10/2010
Labeler - TRIGEN Laboratories, Inc. (830479668)
Revised: 09/2011
 
TRIGEN Laboratories, Inc.
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