RE-Nata 29 OB Prenatal Vitamin Tablets

Generic Name: prenatal vitamin
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 OB Prenatal Vitamin Tablets

DESCRIPTION:

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

INACTIVE INGREDIENTS:

RE-Nata 29 OB Prenatal Vitamins 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 OB 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 OB 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 OB 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.

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 has not been established.

ADVERSE REACTIONS:

Allergic sensitivity reactions and gastrointestinal disturbances may occur. By taking RE-Nata 29 OB 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 OB Prenatal Vitamin Tablets are supplied as round, white tablets, debossed with “RE 394,” in bottles of 90 tablets (NDC # 68032-394-90). 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. 04/09 394-11

PACKAGING:

RE NATA OB  
beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, iron pentacarbonyl, potassium iodide, zinc oxide, cupric oxide, magnesium oxide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-394
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 4000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 3 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 8 ug
BIOTIN (BIOTIN) BIOTIN 30 ug
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 29 mg
POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC) ZINC OXIDE 15 mg
CUPRIC OXIDE (CUPRIC OXIDE) CUPRIC OXIDE 3 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
CROSCARMELLOSE SODIUM  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code RE;394
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-394-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/14/2009 06/30/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011
 
River's Edge Pharmaceuticals, LLC



Hide
(web2)