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HemeNatal OB plus DHA

Generic name: prenatal multivitamin, multimineral and omega-3 fatty acid
Dosage form: tablets, softgel capsules
Drug class: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Nov 23, 2020.

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.

DESCRIPTION:

Each tablet contains:

Supplement Facts

Serving Size: 1 Tablet

Amount Per Serving

Vitamin D 3 (as cholecalciferol)

Vitamin E (as d-alpha tocopheryl succinate)

Vitamin B 1 (as thiamin mononitrate)

Vitamin B 2 (as riboflavin)

Vitamin B 3 (niacin as niacinamide)

Vitamin B 6 (as pyridoxine HCl)

Folic acid

Vitamin B 12 (as cyanocobalamin)

Biotin

Vitamin B 5 (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


Each softgel capsule contains:

Supplement Facts

Serving Size: 1 Softgel Capsule

Amount Per Serving


Total omega-3 long chain fatty acids

as DHA (docosahexaenoic acid)

as ALA (alpha-linolenic acid)

as DPA (docosapentaenoic acid)






203 mg

200 mg

0.5 mg

2.5 mg

OTHER INGREDIENTS: gelatin, glycerin, rice bran oil, purified water

INDICATIONS AND USAGE:​

HemeNatal 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:

HemeNatal OB + DHA, NDC 76331-904-30, is a 30-day regimen supplied in a carton containing one child-resistant bottle of 30 maroon tablets, imprinted “581”, and one child-resistant bottle of 30 softgel capsules. Bottles are 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
1000 N. West St., Suite 1200, #894
Wilmington, DE 19801

HemeNatal OB plus DHA
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, doconexent, linolenic acid, osbond acid kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76331-904
Packaging
# Item Code Package Description
1 NDC:76331-904-30 1 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
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
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 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 (FERROUS CATION) FERROUS CATION 6 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 250 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.5 mg
SODIUM SELENATE (SELENATE ION) SELENIUM 65 ug
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 0.8 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
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:76331-901-30 30 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 04/30/2019
Part 2 of 2
HEMENATAL OB DHA
doconexent, linolenic acid, osbond acid capsule
Product Information
Item Code (Source) NDC:76331-903
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 200 mg
LINOLENIC ACID (LINOLENIC ACID) LINOLENIC ACID 0.5 mg
OSBOND ACID (OSBOND ACID) OSBOND ACID 2.5 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:76331-903-30 30 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 03/08/2012 04/30/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/08/2012 04/30/2019
Labeler - WH Nutritionals, LLC (968642293)
WH Nutritionals, LLC