Zatean-Pn DHA

Manufacturer
Trigen Laboratories, LLC
Effective date
2020-05-28
Label type
DIETARY SUPPLEMENT
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:11:38

Label at a glance#

ProductZatean-Pn DHA
Active ingredientLevomefolic Acid, Folic acid, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, CYANOCOBALAMIN, calcium carbonate, ferrous fumarate, magnesium oxide, Doconexent
Label structure12 sections

Dosage and administration

Take one softgel capsule by mouth daily or as prescribed by a physician.

Label contents#

Full prescribing information#

SUPPLEMENT FACTS

STATEMENT OF IDENTITY SECTION

Zatean Pn DHA Supplement Facts Panel Rev. 07/2019
Zatean Pn DHA Supplement Facts Panel Rev. 07/2019

Other Ingredients: Gelatin Capsule (Bovine gelatin, glycerin, purified water, sorbitol, ethyl vanillin, titanium dioxide, FD&C Yellow #5, FD&C Blue #1), yellow beeswax, soybean oil, soy lecithin, natural & artificial orange cream flavor, citric acid, potassium citrate


THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).

 
Zatean™- Pn DHA is a prescription prenatal/postnatal multivitamin/ mineral softgel with an essential fatty acid and is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including soy or fish products.

WARNING

WARNINGS SECTION

Administration of omega-3 fatty acids – including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

 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.

PRECAUTIONS

PRECAUTIONS SECTION

General: Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

DRUG INTERACTIONS

HEALTH CLAIM SECTION

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

ADVERSE REACTIONS

HEALTH CLAIM SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates.  Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.  Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

DESCRIPTION

STATEMENT OF IDENTITY SECTION

Zatean™ - Pn DHA is an oblong shaped, dark green soft gelatin capsule containing brown paste, laser etched with white “T580”.

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

Take one softgel capsule by mouth daily or as prescribed by a physician.

HOW SUPPLIED

HEALTH CLAIM SECTION

Zatean™ - Pn DHA is dispensed in bottles of 30 softgel capsules.

PRODUCT CODE 13811-580-30

STORAGE

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

HEALTH CLAIM SECTION

KEEP OUT OF REACH OF CHILDREN.


For use on the order of a healthcare practitioner.


Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088.


                                                                                                          Rev. 05/2020

Customer Service: 1-877-482-3788


Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807

Trigen LogoTrigen Logo

PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

13811-580-30

Zatean™-Pn
DHA

Softgels

30 SOFTGELS

TRIGEN
LABORATORIES

Zatean-Pn DHA Bottle LabelZatean-Pn DHA Bottle LabelZatean-Pn DHA Bottle LabelZatean-Pn DHA Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-580-30EA - Each13811-5804c2c0903-5f98-4e2f-9b12-e2ae214a082212013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROLACTIVE INGREDIENTH4N855PNZ11
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
calcium carbonateACTIVE INGREDIENTH0G9379FGK1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
DoconexentACTIVE INGREDIENTZAD9OKH9JC1
ferrous fumarateACTIVE INGREDIENTR5L488RY0Q1
Folic acidACTIVE INGREDIENT935E97BOY81
Levomefolic AcidACTIVE INGREDIENT8S95DH25XC1
magnesium oxideACTIVE INGREDIENT3A3U0GI71G1
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6Z1
.ALPHA.-TOCOPHEROLACTIVE MOIETYH4N855PNZ11
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
DOCONEXENTACTIVE MOIETYZAD9OKH9JC1
FERROUS CATIONACTIVE MOIETYGW89581OWR1
FOLIC ACIDACTIVE MOIETY935E97BOY81
LEVOMEFOLIC ACIDACTIVE MOIETY8S95DH25XC1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP1
ethyl vanillinINACTIVE INGREDIENTYC9ST449YJ1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1M1
gelatinINACTIVE INGREDIENT2G86QN327L1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
potassium citrate anhydrousINACTIVE INGREDIENT86R1NVR0HW1
soybean oilINACTIVE INGREDIENT241ATL177A1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
waterINACTIVE INGREDIENT059QF0KO0R1
yellow waxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13811-58013811-580-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 327 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / TOPICAL0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
gelatinGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MLOZENGE / BUCCALNAExact identifier — unii candidate
22 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
22 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MPOWDER / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
ethyl vanillinETHYL VANILLINYC9ST449YJCAPSULE / ORAL0.64 mgExact identifier — unii candidate
5 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
FD&C yellow no. 5FD&C YELLOW NO. 5I753WB2F1MELIXIR / ORAL0.15 mgExact identifier — unii candidate
22 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
soybean oilSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
ethyl vanillinETHYL VANILLINYC9ST449YJSYRUP / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
gelatinGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
gelatinGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
yellow waxYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C blue no. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / SUBLINGUAL0.03 mgExact identifier — unii candidate
37 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates

Reported adverse events (FAERS/openFDA)#

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