RE-Nata 29 Prenatal Vitamin Tablets

Name: 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

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.

Dosage and administration

One tablet daily, or as directed by physician.

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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