PRENATAL, DHA- thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, and doconexent 
PureTek Corporation

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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Prenatal + DHA

Prenatal multi-vitamin / mineral tablets with Choline Bitartrate and DHA softgels

Description:

Prenatal + DHA™ includes a light pink coated oblong-shaped tablet with “P658” debossed on one side of the tablet and a natural DHA softgel containing a pale orange oil.

Each tablet contains:

Vitamin B1 (Thiamin Mononitrate)3 mg
Vitamin B2 (Riboflavin)3 mg
Vitamin B6 (Pyridoxine HCl)50 mg
Vitamin B12 (Cyanocobalamin)8 mcg
Vitamin C (Ascorbic acid)120 mg
Niacin (Niacinamide)20 mg
Folic acid1 mg
Iron (Ferrous Fumarate)27 mg
Calcium (Calcium Carbonate)200 mg
Vitamin D3 (Cholecalciferol)10.3 mcg
Vitamin E (DL-Alpha Tocopheryl Acetate)27 mg
Iodine (Potassium Iodide)150 mcg
Zinc (Zinc Oxide)15 mg
Choline Bitartrate55 mg

Tablet Inactive Ingredients:

Maltodextrin, Microcrystalline Cellulose, Croscarmellose Sodium, Modified Starch, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Citric Acid, Talc, Silica, Stearic Acid, Magnesium Stearate, Calcium Sulfate, Bovine Gelatin Hydrolyzed, Sucrose, Dicalcium Phosphate, Corn Starch, Silicon Dioxide, FD&C Red #40/Allura Red AC Aluminum Lake, Partially Hydrogenated Soybean Oil, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.

Each DHA softgel contains:

DHA is an omega-3 fatty acid. The DHA in Prenatal + DHA™ is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to 250 mg of DHA.

Other ingredients in the DHA softgel: Gelatin, High Oleic Sunflower Oil, Glycerin, Ascorbyl Palmitate, Tocopherols,  Polysorbate 80.

Docosahexaenoic Acid (DHA) from Algal Oil250 mg

indications and Usage:

Prenatal + DHA™ is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplement to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatal + DHA™ may be beneficial in improving the nutritional status of women prior to conception.

Contraindications:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Warnings:

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Precautions:

Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

One Prenatal + DHA™ tablet and one Prenatal + DHA™ softgel daily or as directed by a physician.

How Supplied

Prenatal + DHA™ is supplied as six child-resistant blister cards containing 5 Prenatal + DHA™ tablets and 5 Prenatal + DHA™ softgels each - NDC 59088-096-58. 

Storage

Do not use if blister seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Excursions permitted to 15° to 30ºC (59° to 86°F).

To report a serious adverse event or to obtain product information, contact 877-921-7873

Manufactured in the USA by:
PureTek Corporation 

San Fernando, CA 91340

For questions or information 

call toll-free: 877-921-7873

PRINCIPAL DISPLAY PANEL - Carton 

image description

PRENATAL, DHA 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, and doconexent kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-096
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-096-586 in 1 CARTON08/10/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 15 BLISTER PACK
Part 2
Part 1 of 2
PRENATAL 
thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10.3 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL27 ug
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE55 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
GELATIN (UNII: 2G86QN327L)  
SUCROSE (UNII: C151H8M554)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SOYBEAN OIL (UNII: 241ATL177A)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorpink (P658, light, coated) Scoreno score
ShapeCAPSULE (oblong) Size19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 2 of 2
DHA 
doconexent capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
GLYCERIN (UNII: PDC6A3C0OX)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/10/201705/11/2020
Labeler - PureTek Corporation (785961046)

Revised: 5/2020
 
PureTek Corporation