Medication Guide App

Multi-Nate DHA Extra

Generic Name: multivitamin, multi-mineral 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 DHA Extra 295/430mg

Multi-Nate DHA Extra Description

Multi-Nate DHA Extra 295/430 mg is a high-potency, multivitamin, multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid).

Each Multi-Nate tablet contains:


Other Ingredients (Multi-Nate tablet): Mono and Diglycerides, Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Crospovidone, Stearic Acid, Hydroxypropyl Methylcellulose, Titanium Dioxide, Magnesium Stearate, Silicon Dioxide, Acacia, Sodium Alginate, Arabic Gum, Sucrose, Corn Starch, Pea Starch, Gelatin, Dicalcium Phosphate, Triacetin, Hydrogenated Soybean Oil, Carmine Powder CFR73.100/E120, Caramel Color CFR73.85/E150, Polysorbate, Polyethylene Glycol.
Contains Soy.

Each Multi-Nate DHA Extra 295/430 mg enteric-coated softgel capsule contains:
295 mg Docosahexaenoic Acid (DHA) from 430 mg omega-3 fatty acids (tuna oil).


Other Ingredients (Multi-Nate DHA Extra 295/430 mg enteric-coated softgel capsule): Gelatin, Water, Glycerin, Polysorbate 80, Ethylcellulose, Sodium Alginate, Oleic Acid, Fractionated Coconut Oil, Purified Stearic Acid, Ammonium Hydroxide.

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

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

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. 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 DHA Extra 295/430 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 tablet is manufactured in a drug-certified cGMP (current good manufacturing practices) facility and meets or exceeds USP standards for potency, purity and dissolution. Each Multi-Nate DHA Extra 295/430 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 Extra

Multi-Nate DHA Extra 295/430 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 DHA Extra 295/430 mg is also useful in improving the nutritional status prior to conception.

Multi-Nate DHA Extra Dosage and Administration

Before, during and after pregnancy, adult women (over 12 years of age), take one (1) tablet and one (1) enteric-coated 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 DHA Extra 295/430 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 (Addisonian 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 DHA Extra 295/430 mg, when taken after meals, may control occasional G.I. disturbances. Multi-Nate DHA Extra 295/430 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 DHA Extra 295/430 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 DHA Extra 295/430 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 Extra Supplied

Multi-Nate DHA Extra 295/430 mg NDC: 68032-448-30 is a 30-day regimen supplied as one bottle of Multi-Nate NDC: 68032-340-30, containing 30 dark red tablets imprinted “RE 340” and one bottle of Multi-Nate DHA Extra 295/430 mg NDC: 68032-452-30, containing 30 yellow enteric-coated 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

RESERVED FOR PROFESSIONAL RECOMMENDATION: Made in the USA exclusively for River’s Edge Pharmaceuticals, LLC, Suwanee, GA, 30024. All rights reserved. Copyright © by River’s Edge Pharmaceuticals.

PACKAGING

MULTINATE DHA  EXTRA
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:68032-448
Packaging
# Item Code Package Description
1 NDC:68032-448-30 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:68032-340    
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 3 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  
TITANIUM DIOXIDE  
TRIACETIN  
POLYSORBATE 20  
GELATIN  
Product Characteristics
Color red (dark red) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;340
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-340-30 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 03/31/2012
Part 2 of 2
MULTINATE DHA  EXTRA
omega-3-acid ethyl esters, doconexent capsule, coated
Product Information
Item Code (Source) NDC:68032-452    
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 430 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 295 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
WATER  
GLYCERIN  
POLYSORBATE 80  
SODIUM ALGINATE  
POLYETHYLENE GLYCOL  
MEDIUM-CHAIN TRIGLYCERIDES  
OLEIC ACID  
STEARIC ACID  
AMMONIA  
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;452
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-452-30 30 CAPSULE, COATED (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 03/31/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/01/2009 03/31/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011
 
River's Edge Pharmaceuticals, LLC
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