TRINAZ- ascorbic acid, cholecalciferol, thiamine hydrochloride, riboflavin, pyridoxal phosphate anhydrous, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, and potassium iodide tablet, film coated

Trinaz by

Drug Labeling and Warnings

Trinaz by is a Other medication manufactured, distributed, or labeled by Foxland Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplement Facts
Serving Size: 1 Tablet	Servings per container: 30
Amount Per Serving:	%DV
Vitamin C (as ascorbic acid)	125 mg	104%
Vitamin D (as cholecalciferol)	12.5 mcg (500 IU)	83%
Thiamin (as thiamine HCl)	1.4 mg	100%
Riboflavin	1.6 mg	100%
Vitamin B6 (as pyridoxal-5-phosphate)	2.5 mg	125%
Folate (as folic acid)	1,667 mcg DFE; 1 mg folic acid	278%
Vitamin B12 (as methylcobalamin)	30 mcg	1,071%
Calcium (from calcium carbonate)	200 mg	15%
Iron (as ferrous gluconate)	12 mg	44%
Iodine (as potassium iodide)	150 mcg	52%

OTHER INGREDIENTS: Microcrystalline Cellulose, Powdered Cellulose, Polyvinyl Alcohol, Polyethylene Glycol, Talc, Titanium Dioxide, Silicon Dioxide, Stearic Acid, Croscarmellose Sodium, Magnesium Stearate, Carmine, FD&C Blue #1, FD&C Blue #2

DESCRIPTION

Trinaz Tablets is a prescription dietary supplement for use throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Trinaz Tablets may be useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

Trinaz Tablets are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNING AND PRECAUTIONS

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTION

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 progress. Trinaz Tablets should only be used under the direction and supervision of a licensed medical practitioner.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling Foxland Pharmaceuticals, Inc. at 1-844-430-7499 or the FDA by calling 1-800-FDA-1088.

DOSAGE & ADMINISTRATION

Usual adult dose is 1 tablet taken orally once or twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED

Trinaz Tablets are available as purple, oblong, film coated tablets imprinted with "225" and are available in 30-count bottles (69067-225-301).

1 Foxland Pharmaceuticals does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

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 heat, light and moisture.

Tamper Evident: Do not use if seal is broken or missing.

HEALTH CLAIM

Distributed by:
Foxland Pharmaceuticals, Inc.
Trussville, AL 35173

This product is not an Orange Book product.

Dispensed by Prescription†

MADE IN USA

Rev. 07/19

†This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).

1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.

1. Federal Register Notice of August 2, 1973 (38 FR 20750)

2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)

3. Federal Register Notice of March 5, 1996 (61 FR 8760)

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

69067-225-30

TRINAZ
Tablets

PRENATAL / POSTNATAL

Dietary Supplement

30 Tablets

Foxland
PHARMACEUTICALS, INC.

INGREDIENTS AND APPEARANCE

TRINAZ 
ascorbic acid, cholecalciferol, thiamine hydrochloride, riboflavin, pyridoxal phosphate anhydrous, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, and potassium iodide tablet, film coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69067-225
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	12.5 ug
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	1.4 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.6 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6)	PYRIDOXAL PHOSPHATE ANHYDROUS	2.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	30 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	12 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARMINIC ACID (UNII: CID8Z8N95N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69067-225-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		08/21/2019

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

Labeler - Foxland Pharmaceuticals, Inc. (079407828)