Medication Guide App

Multi-Nate 30 Prenatal Multivitamin and Minerals

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.

Multi-Nate 30

Other Ingredients

Other Ingredients: Mono and Diglycerides, Croscarmellose Sodium, Microcrystalline Cellulose, Crospovidone, Maltodextrin, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Polyethylene Glycol, Arabic Gum, Gelatin, Sucrose, Pea Starch, Cornstarch, Partially Hydrogenated Soybean Oil, Hydroxypropyl Methylcelluslose, Dicalcium Phosphate, dI-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflaving.
Contains Soy.
May contain Povidone and Polydextrose.

Contains No artificial flavors or preservatives, yeast, wheat (gluten), nuts or milk based by-products.

Indications and Usage for Multi-Nate 30 Prenatal Multivitamin and Minerals

Multi-Nate 30 is 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.

Multi-Nate 30: 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

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.

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 a poison control center immediately.

Warnings

Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture pernicious anemia, it does not ameliorate the attendant neurologic involvement.

Resistance to treatment may be due to depressed hematopoiesis alcoholism, the presence of anti-metabolic drugs, and to deficiencies of vitamins.

Precautions

Folic acid (pteroylglutamic acid) and Vitamin B12 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. Folinic acid (5-formyltetrahydrofolic acid) must be used in that situation. Black tarry stools may be due to either occult GI bleeding or iron therapy or both.

Folic acid may partially correct the hematological damage due to Vitamin B12 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.

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

Multi-Nate 30 Prenatal Multivitamin and Minerals Dosage and Administration

Before, during and after pregnancy, take one tablet by mouth daily, or as directed by a physician.

How is Multi-Nate 30 Prenatal Multivitamin and Minerals Supplied

Multi-Nate 30 is available as a dark pink tablet imprinted “RE 316”: bottles of 100 tablets NDC 68032-444-10. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store a controlled room temperature 15-30C (59-86F).
Keep in a cool, dry place.

WARNING: Keep this and all drugs out of reach of children.
Caution: Rx Only

PACKAGING

MULTI-NATE 30  
beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-444
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 200 mg
IRON (IRON) IRON 29 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC OXIDE 2 mg
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
CROSCARMELLOSE SODIUM  
CELLULOSE, MICROCRYSTALLINE  
CROSPOVIDONE  
MALTODEXTRIN  
STEARIC ACID  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
ACACIA  
SODIUM ALGINATE  
POLYETHYLENE GLYCOL  
SUCROSE  
STARCH, CORN  
HYDROGENATED SOYBEAN OIL  
HYPROMELLOSE 2208 (100 MPA.S)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
ALPHA-TOCOPHEROL, DL-  
TITANIUM DIOXIDE  
TRIACETIN  
POLYSORBATE 20  
RIBOFLAVIN  
Product Characteristics
Color pink Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;316
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-444-10 100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2009 11/30/2011
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC
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