Monday, October 10, 2016

Multi-Nate DHA



multivitamin, multi-mineral nutritional supplement with DHA

Dosage Form: tablet
Multi-Nate 30 DHA 275/400mg

Multi-Nate DHA Description


Multi-Nate 30 DHA 275/400 mg is a high-potency, multivitamin, multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid).


Each Multi-Nate 30 tablet contains:


Vitamin A (beta carotene) 3000 IU, 60% DV

Vitamin B (ascorbic acid) 120 mg, 200% DV

Vitamin D (as cholecalciferol) 400 IU, 100% DV

Vitamin E (as dl-alpha tocopheryl acetate) 30 mg, 100% DV

Vitamin B1 (as thiamine monoitrate) 1.8 mg, 120% DV

Vitamin B2 (as riboflavin) 4 mg, 235% DV

Niacin (as niacinamide) 20 mg, 100% DV

Vitamin B6 (as pyridoxine hydrochloride) 25 mg, 1250% DV

Folic Acid 1 mg, 250% DV

Vitamin B12 (as cyanocobalamin) 12 mcg, 200% DV

Calcium (as calcium carbonate) 200 mg, 20% DV

Iron (as ferrous bisglycinate and iron protein succinylate) 29 mg, 161% DV

Magnesium (as magnesium oxide) 25 mg, 6% DV

Zinc (as zinc oxide) 25 mg, 167% DV

Copper (as cupric oxide) 2 mg, 100% DV


Other Ingredients (Multi-Nate 30 tablet): 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 Methylcellulose, Dicalcium Phosphate, dl-alpha Tocopherol, Titanium Dioxide, Triacetin, Carmine Powder, Polysorbate, Riboflavin.


Contains Soy.


May contain povidone and polydextrose.


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


Each Multi-Nate DHA 275/400 mg softgel capsule contains:

275 mg Docosahexaenoic Acid (DHA) from 400 mg omega-3 fatty acids (tuna oil).


Omega-3 Fatty Acids (from tuna oil) 400 mg, Daily Value not established

    Docosahexaenoic Acid (DHA) 275 mg


Other Ingredients (Multi-Nate DHA 275/400 mg softgel capsule): Gelatin, Water, Glycerin, Polysorbate 80.


Also contains Eicosapentaenoic Acid (EPA) and other Omega-3 Fatty Acids (from tuna oil).

Contains Soy and Fish Oil (from tuna oil).


WARNING: Accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.


Multi-Nate 30 DHA 275/400 mg supplies important prenatal vitamins, minerals and nutrients to supplement the nutritional needs of women, before, during and after pregnancy. Deficiencies of these nutrients are common during pregnancy and lactation and should be prescribed by a physician prior to conception.


Multi-Nate 30 tablet is manufactured in a drug-certified cGMP (current Good Manufacturing Practices) facility and meets or exceeds USP standards for potency, purity and dissolution. Multi-Nate DHA 275/400 mg softgel capsule complies with the most stringent worldwide standards for fish oil and is manufactured in a NSF Certified cGMP Facility.

Indications and Usage for Multi-Nate DHA


Multi-Nate 30 DHA 275/400 mg is a prescription regimen of prenatal multivitamin, multi-mineral and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Multi-Nate 30 DHA 275/400 mg is also useful in improving the nutritional status prior to conception.

Multi-Nate DHA Dosage and Administration


Before, during and after pregnancy, adult women (over 12 years of age), take one (1) tablet and one (1) softgel capsule by mouth daily, between meals or as prescribed by a physician. Tablet and softgel capsule may be taken separately. Do not exceed the recommended dosage. Do not administer to children under 12 years of age or persons age 65 or older. Do not exceed one gram (1,000 mg) of DHA per day.


Contraindications


Multi-Nate 30 DHA 275/400 mg is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. This product is contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms.


WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

Warning


Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.

Precautions


Folic acid in dosages above 400 mcg daily may obscure megaloblastic (pernicious) anemia in that hematological remission can occur while neurological manifestations (Addisionian anemia) remain progressive.

Adverse Reactions


Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, Multi-Nate 30 DHA 275/400 mg, when taken after meals, may control occasional G.I. disturbances, Multi-Nate 30 DHA 275/400 mg is best absorbed when taken at bedtime.


Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.


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

USE IN SPECIFIC POPULATIONS


Multi-Nate 30 DHA 275/400 mg is not advocated for pediatric or geriatric use.

OVERDOSE


Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities have resulted. Multi-Nate 30 DHA 275/400 mg should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

How is Multi-Nate DHA Supplied


Multi-Nate 30 DHA 275/400 mg NDC: 68032-445-30 is a 30-day regimen supplied as one bottle of Multi-Nate 30 NDC: 68032-316-30, containing 30 dark pink tablets imprinted “RE 316” and one bottle of Multi-Nate DHA 275/400 mg NDC: 68032-449-30, containing 30 yellow softgel capsules. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.


CAUTION: Rx Only

PACKAGING


Sample Carton Packaging (68032-445-30):



Sample Labeling (68032-316-30):



Sample Labeling (68032-449-30):
























MULTINATE DHA 
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, omega-3-acid ethyl esters, doconexent  kit






Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-445










Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-445-301 KIT In 1 CARTONNone











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE  30 
Part 21 BOTTLE  30 



Part 1 of 2
MULTINATE 
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
NDC Product Code (Source)68032-316  
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 
HYPROMELLOSES 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
ALPHA-TOCOPHEROL, DL- 
TITANIUM DIOXIDE 
TRIACETIN 
POLYSORBATE 20 
RIBOFLAVIN 
GELATIN 


















Product Characteristics
Colorpink (dark pink)Scoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeRE;316
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-316-3030 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/200911/30/2012




Part 2 of 2
MULTINATE DHA 
omega-3-acid ethyl esters, doconexent  capsule










Product Information
NDC Product Code (Source)68032-449  
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS)OMEGA-3-ACID ETHYL ESTERS400 mg
DOCONEXENT (DOCONEXENT)DOCONEXENT275 mg












Inactive Ingredients
Ingredient NameStrength
GELATIN 
WATER 
GLYCERIN 
POLYSORBATE 80 


















Product Characteristics
ColoryellowScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeRE;449
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-449-3030 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/200911/30/2012











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/200911/30/2012


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

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