Trinatal Rx 1 Prenatal Multivitamin/Mineral Tablet

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.

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

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.

Trinatal Rx 1 is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

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.

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

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

Trinatal Rx 1 is supplied in bottles of 100 tablets.

Product Code: 13811-007-10

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.

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 1-800-444-5164 or FDA at 1-800-FDA-1088.

PI-TRX-00001-2                                                   Rev. 05/2023

Manufactured for:

Trigen Laboratories, LLC

Alpharetta, GA 30005

13811-007-10

100 Tablets

Trinatal Rx 1
(one tablet daily)

Prenatal Multivitamin/Multimineral Tablet

TRIGEN
LABORATORIES