RE Prenatal Multivitamin with Iron

RE PRENATAL MULTIVITAMIN WITH IRON   - vitamin a, cholecalciferol, alpha-tocopherol, ascorbic acid, folic acid, riboflavin, thiamine mononitrate, niacinamide, pyridoxine hydrochloride, cyanocobalamin and iron tablet 
River's Edge Pharmaceuticals, LLC

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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:

label

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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-388
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (VITAMIN A) VITAMIN A1000 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL11 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE2 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN12 ug
IRON (IRON) IRON29 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 
SUCROSE 
D&C RED NO. 7 
STEARIC ACID 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorredScore no score
ShapeROUNDSize13mm
FlavorImprint Code RE;388
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-388-9090 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/19/200909/30/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011River's Edge Pharmaceuticals, LLC