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HemeNatal 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.

HemeNatal OB (Prenatal Multivitamin - Multimineral Tablets)

DESCRIPTION:

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving
Vitamin D3 (as cholecalciferol)
Vitamin E (as d-alpha tocopheryl succinate)
Vitamin B1 (as thiamin mononitrate)
Vitamin B2 (as riboflavin)
Vitamin B3 (niacin as niacinamide)
Vitamin B6 (as pyridoxine HCl)
Folic acid
Vitamin B12 (as cyanocobalamin)
Biotin
Vitamin B5 (as d-calcium pantothenate)
Iron (as polysaccharide iron complex)
       (as heme iron polypeptide)
Iodine (as potassium iodide)
Zinc (as zinc oxide)
Selenium (as sodium selenate)
Copper (as cupric sulfate)



400 IU
10 IU
1.5 mg
1.6 mg
17 mg
50 mg
1 mg
12 mcg
30 mcg
10 mg
28 mg
6 mg
250 mcg
4.5 mg
65 mcg
0.8 mg
OTHER INGREDIENTS: microcrystalline cellulose, starch, silicon dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C red no. 40 aluminum lake, FD&C blue no. 1 & no. 2 aluminum lake

INDICATIONS AND USAGE:

HemeNatal 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.

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:

HemeNatal OB is supplied as a maroon tablet, imprinted “581”, in child-resistant bottles of 90 tablets, NDC 76331-901-90. Tamper evident by foil seal under cap.  

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature].

Manufactured for:
WH Nutritionals, LLC
1000 N. West St., Suite 1200, #894
Wilmington, DE 19801
HemeNatal OB  
cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, sodium selenate, cupric sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76331-901
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL SUCCINATE, D- 10 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE ION 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.6 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 30 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg
IRON SUCROSE (FERRIC CATION) FERRIC CATION 28 mg
HEME IRON POLYPEPTIDE (HEME IRON POLYPEPTIDE) HEME IRON POLYPEPTIDE 6 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 250 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.5 mg
SODIUM SELENATE (SELENATE ION) SELENATE ION 65 ug
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION .8 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
TALC  
FD&C RED NO. 40  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
Product Characteristics
Color red (maroon) Score no score
Shape CAPSULE (caplet) Size 21mm
Flavor Imprint Code 581
Contains         
Packaging
# Item Code Package Description
1 NDC:76331-901-90 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 03/08/2012
Labeler - WH Nutritionals, LLC (968642293)
Revised: 10/2012
 
WH Nutritionals, LLC



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