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 
WH Nutritionals, LLC

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.

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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

Vitamin C (as sodium ascorbate) 120 mg
Vitamin D3 (as cholecalciferol) 450 IU
Vitamin E (as d-alpha tocopheryl acetate) 30 IU
Vitamin B1 (as thiamine mononitrate) 3 mg
Vitamin B2 (as riboflavin) 3 mg
Niacin (as niacinamide) 20 mg
Vitamin B6 (as pyridoxine HCl) 50 mg
Folic acid 1000 mcg
Vitamin B12 (as cyanocobalamin) 10 mcg
Calcium 200 mg
(as calcium formate) 155 mg
(as calcium carbonate) 45 mg
Iron (as ferrous II bis-glycinate chelate) 32 mg
Iodine (as potassium iodide) 100 mcg
Zinc (as zinc oxide) 10 mg
Choline (as choline bitartrate) 55 mg

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

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.

Each softgel capsule contains:

Supplement Facts
Serving Size: 1 Softgel Capsule

DHA (docosahexaenoic acid) 230 mg
EPA (eicosapentaenoic acid) 30 mg

OTHER INGREDIENTS: 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:

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

v1 Rev. 02/2012 844239

carton.jpg

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76331-908
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76331-908-301 in 1 CARTON; Type 1: Convenience Kit of Co-Package05/03/201210/31/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 30 
Part 21 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL450 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN10 ug
CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION155 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION45 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION32 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE100 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg
CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE55 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULE (caplet) Size21mm
FlavorImprint Code 905
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76331-905-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/03/201210/31/2014
Part 2 of 2
NUTRI-TAB OB DHA 
doconexent, icosapent capsule
Product Information
Item Code (Source)NHRIC:76331-907
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT230 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT30 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
RICE BRAN OIL (UNII: LZO6K1506A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (glossy, transparent) Scoreno score
ShapeCAPSULE (oblong) Size14mm
FlavorImprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76331-907-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT05/03/201210/31/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/03/201210/31/2014
Labeler - WH Nutritionals, LLC (968642293)

Revised: 12/2017
 
WH Nutritionals, LLC