Polyherbal formulations treating for various diseases bring attention to the human society. The toxicity and its safe dosage should be studied for dose optimization and formulation. The aim of this study was to evaluate acute and repeated oral toxic effect of the hydroalcoholic extract of polyherbal formulation such as flax seed, fenugreek and jamun seed (FFJ) on wistar albino rats. Acute toxicity was tested by single oral stepwise administration of the drug at the dose of 300 mg, 2000 mg and 5000 mg/kg bw. The toxicity and mortality were observed for every 30 minutes for first 24 hours and then day by day for 14 days. At the 29th day, the blood was collected by Sino orbital puncture for analysis of hematological and biochemical parameters. Then the animals were killed by cervical decapitation and organs were separated and weighed. The results showed that no toxic symptoms were observed up to the dose of 2000 mg/kgbw. But slight changes in the stool consistency, tremor, lethargy and sleep were observed at the dose of 5000 mg/kg bw. There is no significant change in the biochemical and liver enzymatic parameters of different treated groups of polyherbal formulations. The control group animals was observed as