Multi-Nate DHA

Generic Name: multivitamin, multi-mineral nutritional supplement with DHA
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 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):

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-445
Packaging
# Item Code Package Description
1 NDC:68032-445-30 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30 
Part 2 1 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
Item Code (Source) NDC:68032-316    
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  
HYPROMELLOSES  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
ALPHA-TOCOPHEROL, DL-  
TITANIUM DIOXIDE  
TRIACETIN  
POLYSORBATE 20  
RIBOFLAVIN  
GELATIN  
Product Characteristics
Color pink (dark pink) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;316
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-316-30 30 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2009 11/30/2012
Part 2 of 2
MULTINATE DHA 
omega-3-acid ethyl esters, doconexent capsule
Product Information
Item Code (Source) NDC:68032-449    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 400 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 275 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
WATER  
GLYCERIN  
POLYSORBATE 80  
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;449
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-449-30 30 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2009 11/30/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2009 11/30/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011
 
River's Edge Pharmaceuticals, LLC
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