Complete-RF Prenatal

Generic Name: 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
Dosage Form: tablet, film coated

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.

Complete-RF Prenatal
Prenatal Multivitamin & Multimineral Tablets

Rx Only

Complete-RF Prenatal Description

Complete-RF Prenatal Tablets are oval, dye free, white, film-coated, oil and water soluble multivitamin/multimineral tablets debossed "T008" on one side.

Each tablet for oral administration contains:
Vitamin C (ascorbic acid) 120 mg
Vitamin D3 (cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate) 30 IU
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
Elemental 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

Citric Acid, Croscarmellose Sodium, Fumed Silica, Gum Arabic, Magnesium Stearate, Microcrystalline Cellulose, PVP K30, Stearic Acid, TriPotassium Citrate.

Indications and Usage for Complete-RF Prenatal

Complete-RF Prenatal 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. Complete-RF Prenatal 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 1.0 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

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in sufficient 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.

Complete-RF Prenatal Dosage and Administration

One tablet daily or as prescribed by a physician.

How is Complete-RF Prenatal Supplied

Complete-RF Prenatal is supplied in bottles of 90 tablets.

NDC 13811-008-90

STORAGE

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

Rev. 11/10

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

Rx Only
NDC 13811-008-90

90 Tablets

Complete-RF
Prenatal

Prenatal Multivitamin/Multimineral Tablets

TRIGEN
LABORATORIES

Complete-RF Prenatal 
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, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-008
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
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 Oxide) Cupric Oxide 2 mg
Docusate Sodium (Docusate) Docusate Sodium 50 mg
Inactive Ingredients
Ingredient Name Strength
Citric Acid Monohydrate  
Croscarmellose Sodium  
Silicon Dioxide  
Acacia  
Magnesium Stearate  
Cellulose, Microcrystalline  
Povidone K30  
Stearic Acid  
Potassium Citrate Anhydrous  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code T008
Contains         
Packaging
# Item Code Package Description
1 NDC:13811-008-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 12/01/2010
Labeler - TRIGEN Laboratories, Inc. (830479668)
Revised: 09/2011
 
TRIGEN Laboratories, Inc.
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