Trinaz

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

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.

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.

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.

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.

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

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

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.

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)

69067-225-30

TRINAZ
Tablets

PRENATAL / POSTNATAL

Dietary Supplement

30 Tablets

Foxland
PHARMACEUTICALS, INC.