RE-Nata 29 Prenatal Vitamin Tablets

Generic Name: cholecalciferol, alpha-tocopherol, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, potassium iodide, zinc oxide and iron pentacarbonyl
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.

RE-Nata 29 Prenatal Vitamin Tablets

DESCRIPTION:

RE-Nata 29 Prenatal Vitamin Tablets are prescription prenatal vitamins.

Dosage Size: 1 Tablet


Amount Per Serving
Vitamin D (D3)
400 IU
Vitamin E (dl-Alpha Tocopheryl Acetate
30 IU
Vitamin C (ascorbic acid)
120 mg
Folic Acid
1 mg
Vitamin B1(Thiamine Mononitrate)
3 mg
Vitamin B2 (Riboflavin)
3 mg
Niacin (Niacinamide)
20 mg
Vitamin B6 (Pyridoxine HCl)
3 mg
Vitamin B12 (Cyanocobalamin)
8 mcg
Calcium (Calcium Carbonate)
200 mg
Iodine (Potassium Iodide)
150 mcg
Zinc (Zinc Oxide)
15 mg
Iron (Carbonyl Iron)
29 mg

INACTIVE INGREDIENTS:

RE-Nata 29 Prenatal Vitamin Tablets also contain carnauba wax, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide.

INDICATIONS AND USAGE:

RE-Nata 29 Prenatal Vitamin Tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period for the lactating and non-lactating mother. It is also useful for improving the nutritional status prior to conception.

RE-Nata 29 Prenatal Vitamin Tablets contain 1 mg folic acid, which is very important in the development of the baby’s spinal column, especially during the first trimester. Women are advised to start taking folate supplementation several weeks before conception and to continue taking them through the first 12 weeks of pregnancy, or longer. It is recommended that all women of childbearing years take supplements containing folic acid.

CONTRAINDICATIONS:

RE-Nata 29 Prenatal Vitamin Tablets are contraindicated in patients with known hypersensitivity to any of its ingredients. Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia or cirrhosis of the liver.

WARNINGS:

Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the hematological profile of pernicious anemia, it does not ameliorate the underlying neurologic involvement.

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: Before prescribing to patients with kidney stones, the calcium content should be considered. Folic acid may partially correct the hematological damage due to deficiency of pernicious anemia, while the associated neurological damage progresses. In rare instances, allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Pediatric Use: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS:

Allergic sensitivity reactions and gastrointestinal disturbances may occur. By taking RE-Nata 29 Prenatal Vitamin Tablets shortly after meals, G.I. disturbances may be controlled.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

One tablet daily, or as directed by physician.

HOW SUPPLIED:

RE-Nata 29 Prenatal Vitamin Tablets are supplied as oval, white tablets, debossed with “RE 402,” in bottles of 90 tablets (NDC # 68032-402-90). Dispense in a tight, light-resistant container with a child resistant closure as defined by the USP.

STORAGE:

Store at controlled room temperature 15°–30°C (59°–86°F). Protect from moisture and excessive heat.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

Mfd. for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Rev. 04/09 402-11

PACKAGING:

RE NATA 
cholecalciferol, alpha-tocopherol, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, calcium carbonate, potassium iodide, zinc oxide, iron pentacarbonyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-402
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 3 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 8 ug
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg
POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC) ZINC OXIDE 15 mg
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 29 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
CROSCARMELLOSE SODIUM  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
HYPROMELLOSE 2208 (100 MPA.S)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape OVAL Size 20mm
Flavor Imprint Code RE;402
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-402-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2009 03/31/2011
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC



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