side effects of Palgic DS and if FDA approved

I have a three year old little boy who began taking this drug Palgic DS on June 6, 2006 and on June 7, 2006 at 3 AM he woke up screaming and saying he was seeing things in the bed like a crocodile so I removed him from the room thinking it was a dream but when I got in my living room he began screaming as well about snakes and spiders and birds as well so he went to school and the school called me and said he was getting undressed because he thought there was snakes in his underwear so I took him to the doctor and he was put in the hospital and was said to be having hallucinations and seizures and was sent to Dallas Texas Childrens hospital where they said that this medicine was the cause but now he is still suffering form these effects and now we no longer sleep with cover or with the lights out he is still seeing things and haveing seizures we have been to the doctor several times and now they are going to start medicating him. Everywhere I have searched I find lawsuits against the manufacturers of this medicine and can't find out if its FDA approved if you can please answer me no one else will. Needing your help

Brandy