Fillable C:DataMy DocumentsDepakote S00121168s001AP

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Package Insert Page 1 (No. 3826 and 7126) NEW DEPAKOTE ER DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS Rx Only BOX WARNING: HEPATOTOXICITY: HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID AND ITS DERIVATIVES. EXPERIENCE HAS INDICATED THAT CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE...
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