TRINATAL RX 1- acetate ion, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, magnesium oxide, ferrous fumarate, cupric oxide, and zinc oxide tablet, film coated

Trinatal Rx 1 by

Drug Labeling and Warnings

Trinatal Rx 1 by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

Other Ingredients: Microcrystalline cellulose, coating (hypromellose, titanium dioxide, polyvinyl alcohol, polyethylene glycol, talc) tripotassium citrate, croscarmellose sodium, citric acid, povidone K30, acacia, stearic acid, magnesium stearate, fumed silica.

Trinatal Rx 1 tablets help assure an adequate intake of the vitamins and minerals listed. Folate supplementation may be recommended for individuals who have higher-than-normal demands for folate such as pregnant women.

CONTRAINDICATIONS

Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson’s disease.

WARNINGS

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 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 assessment, such that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. The calcium content should be considered before prescribing for patients with history of kidney stones. Do not exceed the recommended dose.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone test, 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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Safety and effectiveness in elderly patients have not been established.

DRUG INTERACTIONS

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

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

DESCRIPTION

Trinatal Rx 1 is an oval shaped, white film-coated tablet debossed "TL388".

DIRECTIONS FOR USE

Take One (1) tablet daily or as prescribed by a physician.

HOW SUPPLIED

Trinatal Rx 1 is supplied in bottles of 100 tablets.

Product Code: 13811-007-10

STORAGE

Store at 20°-25°C (68°-77°F), excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP with a child-resistant closure.

HEALTH CLAIM

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 at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Customer Service: 1-888-987-4436                                                                                                                                                                Rev. 07/2018

Manufactured for:

Trigen Laboratories, LLC

Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-007-10

100 Tablets

Trinatal Rx 1
(one tablet daily)

Prenatal Multivitamin/Multimineral Tablet

TRIGEN
LABORATORIES

INGREDIENTS AND APPEARANCE

TRINATAL RX 1 
acetate ion, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, magnesium oxide, ferrous fumarate, cupric oxide, and zinc oxide tablet, film coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetate ion (UNII: 569DQM74SC) (acetate ion - UNII:569DQM74SC)	acetate ion	3600 [iU]
.beta.-carotene (UNII: 01YAE03M7J) (.beta.-carotene - UNII:01YAE03M7J)	.beta.-carotene	400 [iU]
cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41)	cholecalciferol	400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	15 [iU]
ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ascorbic acid	80 mg
folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	folic acid	1 mg
thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.5 mg
riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	riboflavin	1.6 mg
niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	niacinamide	17 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	pyridoxine Hydrochloride	4 mg
cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	cyanocobalamin	2.5 ug
biotin (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	biotin	30 ug
calcium pantothenate (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	7 mg
calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	calcium carbonate	200 mg
magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	magnesium oxide	100 mg
ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	60 mg
cupric oxide (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	3 mg
zinc oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	zinc oxide	25 mg

Inactive Ingredients
Ingredient Name	Strength
cellulose, microcrystalline (UNII: OP1R32D61U)
hypromelloses (UNII: 3NXW29V3WO)
titanium dioxide (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
talc (UNII: 7SEV7J4R1U)
potassium citrate anhydrous (UNII: 86R1NVR0HW)
croscarmellose sodium (UNII: M28OL1HH48)
citric acid monohydrate (UNII: 2968PHW8QP)
povidone K30 (UNII: U725QWY32X)
acacia (UNII: 5C5403N26O)
stearic acid (UNII: 4ELV7Z65AP)
magnesium stearate (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-007-10	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		03/01/2009

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	19 mm

Labeler - Trigen Laboratories, LLC (830479668)