The acute and subacute toxicity of the aqueous extract of Salvia scutellarioides (Lamiaceae) was studied in mice and rats. In the acute toxicity test, oral administration of 2g/kg of Salvia scutellarioides produced neither mortality nor changes in behavior or any other physiological activities. In subacute toxicity studies, no mortality was observed when the two doses of 1 or 2g/kgday of aqueous extract of Salvia scutellarioides extract were administered orally for a period of 28 days. In the blood chemistry analysis, no significant changes occurred, including glucose, creatinine, blood urea nitrogen (BUN), aspartate transaminase (AST), alanine transaminase (ALT), potassium, sodium, chloride, calcium, phosphorus, conjugated billirrubin, total billirrubin, total cholesterol, high density lipoprotein (HDL), triglycerides, total protein, albumin, prothrombin time (PT) and thromboplastin partial time (PTT) of both sexes. Hematological analysis showed no differences in any of the parameters examined (WBC count, platelet and hemoglobin estimation) in either the control or treated group of both sexes. The urinalysis was negative for glucose, ketonic bodies, casts, red blood cells, and albumin in the control and treatment groups. There were no significant differences in the body and organ weights between controls and treated animals of both sexes. Pathologically, neither gross abnormalities nor histopathological changes were observed.