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Nutri-Tab OB

Generic Name: prenatal multivitamin, multimineral
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 (Prenatal Multivitamin - Multimineral Tablets)

DESCRIPTION:

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

INDICATIONS AND USAGE:

Nutri-Tab OB is a prescription pre/post-natal multivitamin, multimineral 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.

This product contains formate, which if consumed above the recommended level, could cause visual impairment and other effects on health. Do not exceed recommended dosage.

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 daily with or without food or as prescribed by a physician.

HOW SUPPLIED:

Nutri-Tab OB is supplied as an orange tablet, imprinted “905”, in child-resistant bottles of 90 tablets, NDC 76331-905-90. Tamper evident by foil seal under cap.

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

Manufactured for:
WH Nutritionals, LLC
1000 N. West St., Suite 1200, #894
Wilmington, DE 19801
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
Product Type HUMAN PRESCRIPTION DRUG LABEL 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:76331-905-90 90 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
Labeler - WH Nutritionals, LLC (968642293)
Revised: 10/2012
 
WH Nutritionals, LLC



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