RE Prenatal Multivitamin with Iron

Generic Name: vitamin a, cholecalciferol, alpha-tocopherol, ascorbic acid, folic acid, riboflavin, thiamine mononitrate, niacinamide, pyridoxine hydrochloride, cyanocobalamin and iron
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 Prenatal Multivitamin with Iron

DESCRIPTION:

RE Prenatal Multivitamins with Iron Chewable Tablets are wildberry-flavored prescription prenatal chewable vitamins.

Nutrition Facts
Dosage Size 1 Chewable Tablet
Amount Per Serving

Vitamin A (beta-carotene) ................................ 1000 IU
Vitamin D3 (cholecalciferol) ................................ 400 IU
Vitamin E (dl-alpha tocopheryl acetate) ................ 11 IU
Vitamin C
(sodium ascorbate and ascorbic acid) ........... 120 mg
Folic Acid ............................................................. 1 mg
Thiamine Mononitrate (vitamin B1) ....................... 2 mg
Riboflavin (vitamin B2).......................................... 3 mg
Niacinamide ...................................................... 20 mg
Vitamin B6 (pyridoxine HCl) ................................. 10 mg
Vitamin B12 (cyanocobalamin) ........................... 12 mcg
Iron (as ferrous fumarate) .................................. 29 mg

INACTIVE INGREDIENTS:

RE Prenatal Multivitamins with Iron Chewable Tablets also contain polyethylene glycol, sugar, D/C Red #7 calcium lake, stearic acid, magnesium stearate, flavor, microcrystalline cellulose.

INDICATIONS:

RE Prenatal Multivitamins with Iron Chewable 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 Prenatal Multivitamins with Iron Chewable Tablets contains 1 mg folic acid, which is very important in the development of the baby’s spinal column during a specific period of time. 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 Prenatal Multivitamins with Iron Chewable 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:

Folic acid (pteroylglutamic acid) and Vitamin B microbiological blood assays are invalidated by the administration of most antibiotics, methotrexate and pyrimethamine. Folic acid (pteroylglutamic acid) is not effective reversing the toxic effects of methotrexate. 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.

ADVERSE REACTIONS:

Allergic sensitivity reactions and gastrointestinal disturbances may occur. By taking RE Prenatal Multivitamins with Iron Chewable 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 Prenatal Multivitamins with Iron Chewable Tablets are supplied as round, red tablets, debossed with “RE 388,” in bottles of 90 tablets, NDC# 68032-388-90.

Dispense in a tight, light-resistant container with a child resistant closure as defined by the USP.

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

PACKAGING:

RE Prenatal Multivitamin with Iron  
vitamin a, cholecalciferol, alpha-tocopherol, ascorbic acid, folic acid, riboflavin, thiamine mononitrate, niacinamide, pyridoxine hydrochloride, cyanocobalamin, iron tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-388
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 1000 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 11 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
IRON (IRON) IRON 29 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL  
SUCROSE  
D&C RED NO. 7  
STEARIC ACID  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
Product Characteristics
Color red Score no score
Shape ROUND Size 13mm
Flavor Imprint Code RE;388
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-388-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/19/2009 09/30/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011
 
River's Edge Pharmaceuticals, LLC



Hide
(web3)