RE-Nata 29 OB Prenatal Vitamin Tablets

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

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.

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.

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

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