Prenatal, DHA

Manufacturer
PureTek Corporation
Effective date
2019-05-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:24:12

Label at a glance#

ProductPrenatal, DHA
Active ingredientTHIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ASCORBIC ACID, NIACIN, FOLIC ACID, FERROUS FUMARATE, CALCIUM CARBONATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, POTASSIUM IODIDE, ZINC OXIDE, CHOLINE BITARTRATE, DOCONEXENT
Label structure10 sections

Indications and uses

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.

Dosage and administration

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

Storage and handling

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  cal...

Label contents#

Full prescribing information#

Description:

DESCRIPTION SECTION

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:

DESCRIPTION SECTION

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:

SPL UNCLASSIFIED SECTION

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:

DESCRIPTION SECTION

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:

INDICATIONS & USAGE SECTION

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:

CONTRAINDICATIONS SECTION

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.

Boxed Warning section

Warnings:

WARNINGS SECTION

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:

PRECAUTIONS SECTION

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:

ADVERSE REACTIONS SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

How Supplied

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

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 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-096-58EA - Each59088-096f527ae3d-9910-443b-b032-6c2e47fa3eb412018-03-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 54 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-09659088-096-58

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a5691c98-d928-2797-e053-2995a90ac64de8b17c58-8670-405a-8189-5e6f2acff6f62020-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: e8b17c58-8670-405a-8189-5e6f2acff6f6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.