Rena-Vite Tablets

General: Product/Version Code

Product Code 60258-160-01

FDA Statement of Identity

Dietary Supplement

Precautions re: All Other

Do not use if imprinted safety seal under cap is broken or missing.

Suggested/Recommended/Usage/Directions

Directions: One tablet daily or as directed by a physician.

Precautions re: All Other

Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient. Precautions: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in 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.

Precautions re: Allergies

Adverse reactions: Allergic sensitization has been reported following both oral and paranteral administration of folic acid.

Storage

Storage: Store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

Precautions re: Children

Keep this product out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center imeediately.

Precautions re: All Other

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact Cypress Pharmaceutical, Inc. at 1-800-793-2145 or FDA at 1-800-FDA-1088 (Toll free).

General Statements: All Other Content

The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance and state level reimbursement programs and is not intended to denote registration with the FDA.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.