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

Prenatal, DHA by

Drug Labeling and Warnings

Prenatal, DHA by is a Prescription medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 acid: 1 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 Bitartrate: 55 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 Oil	250 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 

INGREDIENTS AND APPEARANCE

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59088-096

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-096-58	6 in 1 CARTON	08/10/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	5 BLISTER PACK	5
Part 2		5

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 Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	50 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	8 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A)	NIACIN	20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10.3 ug
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	27 ug
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 mg
CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X)	CHOLINE	55 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (P658, light, coated)	Score	no score
Shape	CAPSULE (oblong)	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other

Part 2 of 2

DHA 
doconexent capsule, liquid filled

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	250 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/10/2017

Labeler - PureTek Corporation (785961046)