Indications and uses
Zatean™ - Pn is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
Zatean™-Pn Tablets
- Manufacturer
- Trigen Laboratories, Inc.
- Effective date
- 2013-05-15
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:40:53
Label at a glance#
ProductZatean-Pn
Active ingredient.beta.-carotene, ascorbic acid, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine Hydrochloride, Levomefolate Calcium, cholecalciferol, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, potassium iodide, ferrous fumarate
Label structure13 sections
Dosage and administration
One tablet daily or as directed by a physician.
Contacts and useful links#
Websitewww.trigenlab.com
www.trigenlab.com
www.trigenlab.comLabel contents#
Full prescribing information#
DESCRIPTION
Zatean™ - Pn is a prescription prenatal/postnatal multivitamin/mineral tablet. Zatean™ - Pn are oval, white tablets with "M605"debossed on one side.
| Supplement Facts Servings per Bottle: 90 | ||
|---|---|---|
| Serving Size: 1 Tablet Each Tablet contains | %DV for Pregnant and Lactating Women | |
| Folate | 1 mg | 125% |
| (L-methylfolate, or 6(S)-5-MTHF 600 mcg) (folic acid, USP 400 mcg) | ||
| Vitamin A (100% as beta-carotene) | 2500 IU | 31% |
| Vitamin C (ascorbic acid) | 80 mg | 133% |
| Vitamin D3 (cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-alpha tocopheryl acetate) | 10 IU | 33% |
| Vitamin B1 (thiamine mononitrate) | 3 mg | 176% |
| Vitamin B2 (riboflavin) | 3.4 mg | 170% |
| Niacinamide | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl) | 20 mg | 800% |
| Vitamin B12 | 12 mcg | 150% |
| Biotin | 300 mcg | 100% |
| Pantothenic acid (calcium pantothenate) | 6 mg | 60% |
| Calcium (calcium carbonate) | 120 mg | 9% |
| Iron (ferrous fumarate) | 27 mg | 150% |
| Iodine (potassium iodide) | 150 mcg | 100% |
| Magnesium (magnesium oxide) | 30 mg | 7% |
| Zinc (zinc oxide) | 15 mg | 100% |
| Copper (copper oxide) | 2 mg | 100% |
Inactive Ingredients: Microcrystalline Cellulose, White Coating (Polyvinyl Alcohol, Titanium Dioxide, Talc, Polyethylene Glycol), Sodium Carboxymethyl Starch, TriPotassium Citrate, Citric Acid, fumed Silica, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Ascorbyl Palmitate, Povidone K30, Acacia.
INDICATIONS AND USAGE
Zatean™ - Pn 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.
WARNINGS SECTION
| 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
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
PATIENT INFORMATION
Zatean™ - Pn is a prescription vitamin for use only under the direction and supervision of a licensed physician.
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.
Drugs which may interact with folate include:
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the levels of this AED in the blood and allowing breakthrough seizures to occur.
- Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
- Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
- Colestipol: Reduces folic acid absorption and reduces serum folate levels.
- Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
- Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
- Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
- Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
- Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
- Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
- Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
- Smoking and alcohol: Reduced serum folate levels have been noted.
- Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
- Metformin treatment in patients with type 2 diabetes decreases serum folate.
- Warfarin can produce significant impairment in folate status after a 6 - month therapy.
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 cyanocobolamin.
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
HOW SUPPLIED
Zatean™ - Pn is dispensed in bottles of 90 tablets.
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].
PRODUCT CODE 13811-581-90
HEALTH CLAIM SECTION
KEEP OUT OF REACH OF CHILDREN
Rx Only
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 04/13
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
13811-581-90
Rx Only
Zatean™-Pn
Tablets
90 TABLETS
TRIGEN
LABORATORIES
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-581-90 | EA - Each | 13811-581 | 817c5d49-50fc-4cbc-8fa3-18a6b1e7a1f6 | 1 | 2013-06-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .alpha.-tocopherol acetate, dl- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| .beta.-carotene | ACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| ascorbic acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| biotin | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| calcium carbonate | ACTIVE INGREDIENT | H0G9379FGK | 1 | |
| calcium pantothenate | ACTIVE INGREDIENT | 568ET80C3D | 1 | |
| cholecalciferol | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| ferrous fumarate | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| folic acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Levomefolate Calcium | ACTIVE INGREDIENT | A9R10K3F2F | 1 | |
| niacinamide | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| potassium iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| thiamine mononitrate | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| .beta.-carotene | ACTIVE MOIETY | 01YAE03M7J | 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 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| folic acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| IODIDE ION | ACTIVE MOIETY | 09G4I6V86Q | 1 | |
| LEVOMEFOLIC ACID | ACTIVE MOIETY | 8S95DH25XC | 1 | |
| niacinamide | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| riboflavin | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| acacia | INACTIVE INGREDIENT | 5C5403N26O | 1 | |
| ascorbyl palmitate | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| potassium citrate anhydrous | INACTIVE INGREDIENT | 86R1NVR0HW | 1 | |
| povidone K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Zatean-Pn
- .beta.-carotene, ascorbic acid, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine Hydrochloride, Levomefolate Calcium, cholecalciferol, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, potassium iodide, and ferrous fumarate
- .beta.-carotene
- ascorbic acid
- .alpha.-tocopherol acetate, dl-
- .ALPHA.-TOCOPHEROL, DL-
- thiamine mononitrate
- THIAMINE ION
- THIAMINE
- riboflavin
- niacinamide
- pyridoxine Hydrochloride
- PYRIDOXINE
- Levomefolate Calcium
- LEVOMEFOLIC ACID
- cholecalciferol
- folic acid
- cyanocobalamin
- biotin
- calcium pantothenate
- CALCIUM CATION
- calcium carbonate
- potassium iodide
- IODIDE ION
- ferrous fumarate
- FERROUS CATION
- cellulose, microcrystalline
- polyvinyl alcohol
- titanium dioxide
- talc
- polyethylene glycols
- potassium citrate anhydrous
- citric acid monohydrate
- stearic acid
- magnesium stearate
- silicon dioxide
- ascorbyl palmitate
- povidone K30
- acacia
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13811-581 | 13811-581-90 |
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 |
|---|---|---|---|---|---|---|
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| talc | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| povidone K30 | POVIDONE K30 | U725QWY32X | SYSTEM / TRANSDERMAL | 15 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| talc | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| acacia | ACACIA | 5C5403N26O | POWDER / ORAL | 800 mg | ||
| ascorbyl palmitate | ASCORBYL PALMITATE | QN83US2B0N | SOLUTION / TOPICAL | NA | ||
| povidone K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED / ORAL | 245 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION / TOPICAL | 1.4 %w/v | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| povidone K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SUSPENSION / ORAL | 257 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| talc | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| povidone K30 | POVIDONE K30 | U725QWY32X | FILM / SUBLINGUAL | 7 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| povidone K30 | POVIDONE K30 | U725QWY32X | TABLET, CHEWABLE / ORAL | 245 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/v | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | CREAM / VAGINAL | 0.5 %w/w | ||
| cellulose, microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | TABLET, FILM COATED / ORAL | 20 mg | ||
| polyvinyl alcohol | POLYVINYL ALCOHOL | 532B59J990 | AEROSOL, FOAM / VAGINAL | 0.5 %w/w | ||
| talc | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / OPHTHALMIC | 0.03 %w/v | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| talc | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| povidone K30 | POVIDONE K30 | U725QWY32X | PELLET / ORAL | 24 mg | ||
| talc | TALC | 7SEV7J4R1U | DROPS / ORAL | NA |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.