Dosage and administration
Take one softgel capsule by mouth daily or as prescribed by a physician.
Zatean-Pn Plus
- Manufacturer
- Trigen Laboratories, LLC
- Effective date
- 2020-05-28
- Label type
- DIETARY SUPPLEMENT
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:17:50
Label at a glance#
ProductZatean-Pn Plus
Active ingredientLEVOMEFOLIC ACID, folic acid, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, CYANOCOBALAMIN, Biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, Doconexent, Icosapent
Label structure12 sections
Contacts and useful links#
Websitewww.trigenlab.com
www.trigenlab.com
www.trigenlab.comLabel contents#
Full prescribing information#
SUPPLEMENT FACTS
Other Ingredients: Orange Cream Flavor O.S., Citric Acid, Biomin Potassium Citrate, Soy Lecithin, Yellow Beeswax
Shell Ingredients: Bovine Gelatin, Glycerin, Purified Water, Sorbitol, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #5, FD&C Blue #1, and Caramel.
THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).
Zatean™-Pn Plus 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
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients including soy or fish oil.
WARNING
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
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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.
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
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
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
Zatean™ - Pn Plus is an oblong shaped, dark green soft gelatin capsule containing brown paste with white “T582” laser etched.
DIRECTIONS FOR USE
Take one softgel capsule by mouth daily or as prescribed by a physician.
HOW SUPPLIED
Zatean™ - Pn Plus is available in bottles of 30 softgel capsules.
PRODUCT CODE 13811-582-30
STORAGE
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 08807www.trigenlab.com
PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
13811-582-30
Zatean™-Pn
Plus
Softgels
30 SOFTGELS
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-582-30 | EA - Each | 13811-582 | 1c0ac44a-211c-4b41-916a-0dd40ba5a3f6 | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL | ACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Biotin | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| calcium carbonate | ACTIVE INGREDIENT | H0G9379FGK | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Doconexent | ACTIVE INGREDIENT | ZAD9OKH9JC | 1 | |
| ferrous fumarate | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| folic acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Icosapent | ACTIVE INGREDIENT | AAN7QOV9EA | 1 | |
| LEVOMEFOLATE CALCIUM | ACTIVE INGREDIENT | A9R10K3F2F | 1 | |
| magnesium oxide | ACTIVE INGREDIENT | 3A3U0GI71G | 1 | |
| potassium iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| PYRIDOXINE | ACTIVE INGREDIENT | KV2JZ1BI6Z | 1 | |
| .ALPHA.-TOCOPHEROL | ACTIVE MOIETY | H4N855PNZ1 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| Biotin | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| DOCONEXENT | ACTIVE MOIETY | ZAD9OKH9JC | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| ICOSAPENT | ACTIVE MOIETY | AAN7QOV9EA | 1 | |
| IODIDE ION | ACTIVE MOIETY | 09G4I6V86Q | 1 | |
| LEVOMEFOLIC ACID | ACTIVE MOIETY | 8S95DH25XC | 1 | |
| MAGNESIUM CATION | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| caramel | INACTIVE INGREDIENT | T9D99G2B1R | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| ethyl vanillin | INACTIVE INGREDIENT | YC9ST449YJ | 1 | |
| FD&C Blue no. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Yellow no. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| lecithin, soybean | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| potassium citrate anhydrous | INACTIVE INGREDIENT | 86R1NVR0HW | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| yellow wax | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- Zatean-Pn Plus
- LEVOMEFOLATE CALCIUM, folic acid, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, CYANOCOBALAMIN, Biotin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, Doconexent, and Icosapent
- LEVOMEFOLIC ACID
- folic acid
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL
- PYRIDOXINE
- CYANOCOBALAMIN
- Biotin
- calcium carbonate
- CALCIUM CATION
- ferrous fumarate
- FERROUS CATION
- potassium iodide
- IODIDE ION
- magnesium oxide
- MAGNESIUM CATION
- Doconexent
- Icosapent
- caramel
- ethyl vanillin
- FD&C Blue no. 1
- FD&C Yellow no. 5
- gelatin
- glycerin
- lecithin, soybean
- water
- sorbitol
- titanium dioxide
- potassium citrate anhydrous
- yellow wax
- ANHYDROUS CITRIC ACID
- ORANGE OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13811-582 | 13811-582-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| sorbitol | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| lecithin, soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| FD&C Yellow no. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / BUCCAL | 0.11 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| sorbitol | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| sorbitol | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| FD&C Blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| caramel | CARAMEL | T9D99G2B1R | SOLUTION / RECTAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| gelatin | GELATIN | 2G86QN327L | SUPPOSITORY / VAGINAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| gelatin | GELATIN | 2G86QN327L | TABLET / ORAL | 46 mg | ||
| caramel | CARAMEL | T9D99G2B1R | SYRUP / ORAL | 207 mg/5ml | ||
| caramel | CARAMEL | T9D99G2B1R | SOLUTION / ORAL | 11 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| FD&C Yellow no. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | POWDER / TOPICAL | NA | ||
| sorbitol | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| sorbitol | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| caramel | CARAMEL | T9D99G2B1R | LIQUID / ORAL | 5.3 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 385 mg | ||
| FD&C Blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C Yellow no. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | OINTMENT / TOPICAL | 0.01 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | CAPSULE, COATED PELLETS / ORAL | 65 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | ELIXIR / ORAL | 100 mg/5ml | ||
| gelatin | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| lecithin, soybean | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| FD&C Blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| sorbitol | SORBITOL | 506T60A25R | PASTE, DENTIFRICE / DENTAL | 14 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| yellow wax | YELLOW WAX | 2ZA36H0S2V | TABLET, COATED / ORAL | 213.7 mg | ||
| FD&C Blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LOTION / TOPICAL | NA | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAVENOUS | 2068 mg | ||
| FD&C Blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| sorbitol | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| FD&C Blue no. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| FD&C Yellow no. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, CHEWABLE / ORAL | 4.5 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.