Monday, October 10, 2016

Multi-Nate 30 Prenatal Multivitamin and Minerals




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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-444
Route of AdministrationORALDEA Schedule    


















































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETA CAROTENE (BETA CAROTENE)BETA CAROTENE3000 [iU]
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL)ALPHA-TOCOPHEROL30 mg
THIAMINE MONONITRATE (THIAMINE)THIAMINE MONONITRATE1.8 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN4 mg
NIACINAMIDE (NIACINAMIDE)NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (CALCIUM)CALCIUM CARBONATE200 mg
IRON (IRON)IRON29 mg
MAGNESIUM OXIDE (MAGNESIUM)MAGNESIUM OXIDE25 mg
ZINC OXIDE (ZINC)ZINC OXIDE25 mg
CUPRIC OXIDE (CUPRIC CATION)CUPRIC OXIDE2 mg














































Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeRE;316
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-444-10100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/01/200911/30/2011


Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010River's Edge Pharmaceuticals, LLC

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