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Nutri-Tab OB Plus DHA

Generic Name: pre/post-natal multivitamin, multimineral and omega-3 fatty acids
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.

Nutri-Tab OB + DHA (Prenatal Multivitamin - Multimineral Tablets and Omega-3 Fatty Acid Softgel Capsules)

DESCRIPTION:

Each tablet contains:
Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving
Vitamin C (as sodium ascorbate)
Vitamin D3 (as cholecalciferol)
Vitamin E (as d-alpha tocopheryl acetate)
Vitamin B1 (as thiamine mononitrate)
Vitamin B2 (as riboflavin)
Niacin (as niacinamide)
Vitamin B6 (as pyridoxine HCl)
Folic acid
Vitamin B12 (as cyanocobalamin)
Calcium
   (as calcium formate)
   (as calcium carbonate)
Iron (as ferrous II bis-glycinate chelate)
Iodine (as potassium iodide)
Zinc (as zinc oxide)
Choline (as choline bitartrate)



120 mg
450 IU
30 IU
3 mg
3 mg
20 mg
50 mg
1000 mcg
10 mcg
200 mg
155 mg
45 mg
32 mg
100 mcg
10 mg
55 mg
Each softgel capsule contains:
Supplement Facts
Serving Size: 1 Softgel Capsule
Amount Per Serving

DHA (docosahexaenoic acid)
EPA (eicosapentaenoic acid)
   


230 mg
30 mg
OTHER INGREDIENTS (tablets): microcrystalline cellulose, starch, silica, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C yellow #6 aluminum lake

OTHER INGREDIENTS (softgel capsules): gelatin, glycerin, rice bran oil, purified water

INDICATIONS AND USAGE:

Nutri-Tab OB + DHA is a prescription pre/post-natal multivitamin, multimineral and omega-3 fatty acid nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy, as well as in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

WARNINGS AND PRECAUTIONS:

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 poison control center immediately.
Folic acid is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs, and/or supplements should be considered.

Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

DOSAGE AND ADMINISTRATION:

One tablet and one softgel capsule daily with or without food or as prescribed by a physician.

HOW SUPPLIED:

Nutri-Tab OB + DHA, NDC 76331-908-30, is a 30-day regimen supplied in a carton containing one child-resistant bottle of 30 Kosher certified, orange tablets, imprinted “905”, and one child-resistant bottle of 30 softgel capsules. Bottles are tamper evident by foil seal under cap.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Manufactured for:
WH Nutritionals
1000 N. West St., Suite 1200, #894
Wilmington, DE 19801
Nutri-Tab OB Plus DHA  
sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous bisglycinate, potassium iodide, zinc oxide, choline bitartrate, doconexent, icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76331-908
Packaging
# Item Code Package Description
1 NDC:76331-908-30 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE, PLASTIC 30 
Part 2 1 BOTTLE, PLASTIC 30 
Part 1 of 2
NUTRI-TAB OB  
sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous bisglycinate, potassium iodide, zinc oxide, choline bitartrate tablet
Product Information
Item Code (Source) NDC:76331-905    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 450 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE ION 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1000 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
CALCIUM FORMATE (CALCIUM CATION) CALCIUM CATION 155 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 45 mg
FERROUS BISGLYCINATE (FERROUS CATION) FERROUS CATION 32 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 100 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 10 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE 55 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
TALC  
FD&C YELLOW NO. 6  
Product Characteristics
Color orange Score no score
Shape CAPSULE (caplet) Size 21mm
Flavor Imprint Code 905
Contains         
Packaging
# Item Code Package Description
1 NDC:76331-905-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/03/2012
Part 2 of 2
NUTRI-TAB OB DHA  
doconexent, icosapent capsule
Product Information
Item Code (Source) NDC:76331-907    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 230 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 30 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
RICE BRAN OIL  
WATER  
Product Characteristics
Color yellow (glossy, transparent) Score no score
Shape CAPSULE (oblong) Size 14mm
Flavor Imprint Code none
Contains         
Packaging
# Item Code Package Description
1 NDC:76331-907-30 30 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 05/03/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/03/2012
Labeler - WH Nutritionals, LLC (968642293)
Revised: 11/2012
 
WH Nutritionals, LLC



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