Label: ALLOPURINOL tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 23, 2025

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  • DESCRIPTION
    Allopurinol has the following structural formula: Allopurinol is known chemically as 1,5-dihydro-4 - H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is ...
  • CLINICAL PHARMACOLOGY
    Allopurinol acts on purine catabolism, without disrupting the biosynthesis of purines. It reduces the production of uric acid by inhibiting the biochemical reactions immediately preceding its ...
  • INDICATIONS AND USAGE
    THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use ...
  • CONTRAINDICATIONS
    Patients who have developed a severe reaction to allopurinol tablets should not be restarted on the drug.
  • WARNINGS
    ALLOPURINOL TABLETS SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE AN ALLERGIC REACTION. In some instances a skin rash may be followed by more ...
  • PRECAUTIONS
    General - An increase in acute attacks of gout has been reported during the early stages of administration of allopurinol tablets, even when normal or subnormal serum uric acid levels have been ...
  • ADVERSE REACTIONS
    Data upon which the following estimates of incidence of adverse reactions are made are derived from experiences reported in the literature, unpublished clinical trials and voluntary reports ...
  • OVERDOSAGE
    Massive overdosing or acute poisoning by allopurinol tablets has not been reported. In mice, the 50% lethal dose (LD - 50) is 160 mg/kg given intraperitoneally (IP) with deaths delayed ...
  • DOSAGE AND ADMINISTRATION
    The dosage of allopurinol tablets to accomplish full control of gout and to lower serum uric acid to normal or near-normal levels varies with the severity of the disease. The average is 200 to ...
  • HOW SUPPLIED
    100-mg (white) scored, flat cylindrical tablets with "I" and "135" on either side of the break line on one side and plain on other side, bottles of 100 (NDC 23155-693-01) and 1000 (NDC ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    100 mg 100 Tablets Bottle - 100 Tablets NDC 23155-693-01 - Allopurinol Tablets USP - Each scored tablet contains - 100 mg - Rx Only - 100 mg 100 Tablets ...
  • INGREDIENTS AND APPEARANCE
    Product Information