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 
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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HemeNatal OB (Prenatal Multivitamin - Multimineral Tablets)

DESCRIPTION:

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

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.

ADVERE 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

label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:76331-901
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D-10 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE17 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
IRON SUCROSE (UNII: FZ7NYF5N8L) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION28 mg
HEME IRON POLYPEPTIDE (UNII: 31VDO12CJY) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION6 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE250 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.5 mg
SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SELENIUM65 ug
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION0.8 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorred (maroon) Scoreno score
ShapeCAPSULE (caplet) Size21mm
FlavorImprint Code 581
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76331-901-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/08/201206/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/08/201206/30/2018
Labeler - WH Nutritionals, LLC (968642293)

Revised: 12/2018
 
WH Nutritionals, LLC