TRINATAL ULTRA- vitamin a palmitate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium citrate, iron pentacarbonyl, potassium iodide, zinc oxide, cupric oxide, and docusate sodium tablet 
Trigen Laboratories, LLC

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Trinatal Ultra
Tablets

Rx Only

DESCRIPTION

Trinatal Ultra is a prescription prenatal multivitamin/multimineral tablet which contains calcium citrate and carbonyl iron. Each dye-free, oil-and-water soluble, white tablet is debossed "TL615".

Supplement Facts
Servings per Bottle: 100
Serving Size: 1 Tablet
Each Tablet contains
%DV for Pregnant and
Lactating Women
*
Input as Vitamin A palmitate and beta carotene.
Vitamin A (vitamin A palmitate and beta carotene)2700 IU*34%
Vitamin C (ascorbic acid) 120 mg200%
Vitamin D3 (cholecalciferol)400 IU100%
Vitamin E (dl-alpha-tocopheryl acetate)30 IU 100%
Vitamin B1 (thiamine mononitrate)3 mg 176%
Vitamin B2 (riboflavin)3.4 mg 170%
Niacinamide20 mg100%
Vitamin B6 (pyridoxine HCl)20 mg800%
Folic Acid1 mg125%
Vitamin B12 (cyanocobalamin)12 mcg150%
Calcium (calcium citrate)200 mg 15%
Iron, Elemental (carbonyl iron)90 mg500%
Iodine (potassium iodide)150 mcg100%
Zinc (zinc oxide) 25 mg167%
Copper (cupric oxide)2 mg100%
Docusate Sodium50 mg3%

Inactive Ingredients

Microcrystalline Cellulose, TriPotassium Citrate, Croscarmellose Sodium, Magnesium Stearate, Acacia, Citric Acid, Povidone K30, Fumed Silica, Stearic Acid, Hypromellose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc.

INDICATIONS AND USAGE

Trinatal Ultra is a multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Trinatal Ultra can also 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.

WARNINGS

Folic acid alone is 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 neurological manifestations remain progressive.

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

The calcium content should be considered before prescribing for patients with kidney stones. Do not exceed the recommended dose.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac functions, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.

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

DOSAGE AND ADMINISTRATION

Usual dosage is one (1) tablet daily or as prescribed by a physician.

HOW SUPPLIED

Trinatal Ultra is supplied in bottles of 100 tablets.

PRODUCT CODE 13811-615-10

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

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. 05/13

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-615-10
Rx Only

Trinatal Ultra
Tablets

100 Tablets

TRIGEN
LABORATORIES

Principal Display Panel - 100 Tablet Bottle Label
TRINATAL ULTRA 
vitamin a palmitate, .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium citrate, iron pentacarbonyl, potassium iodide, zinc oxide, cupric oxide, and docusate sodium tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-615
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T) Vitamin A1350 [iU]
.beta.-carotene (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .beta.-carotene1350 [iU]
ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ascorbic acid120 mg
cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) riboflavin3.4 mg
niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) niacinamide20 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride20 mg
folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) folic acid1 mg
cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) cyanocobalamin12 ug
calcium citrate (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CITRIC ACID MONOHYDRATE200 mg
iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (ferrous cation - UNII:GW89581OWR) ferrous cation90 mg
potassium iodide (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) potassium iodide150 ug
zinc oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) zinc oxide25 mg
cupric oxide (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
docusate sodium (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) docusate sodium50 mg
Inactive Ingredients
Ingredient NameStrength
cellulose, microcrystalline (UNII: OP1R32D61U)  
potassium citrate anhydrous (UNII: 86R1NVR0HW)  
povidone K30 (UNII: U725QWY32X)  
acacia (UNII: 5C5403N26O)  
croscarmellose sodium (UNII: M28OL1HH48)  
magnesium stearate (UNII: 70097M6I30)  
citric acid monohydrate (UNII: 2968PHW8QP)  
stearic acid (UNII: 4ELV7Z65AP)  
hypromelloses (UNII: 3NXW29V3WO)  
titanium dioxide (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
talc (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-615-10100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT05/01/201105/31/2014
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
imprint
scoring1
shape
size (solid drugs)22 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 11/2019
 
Trigen Laboratories, LLC