Description

Allopurinol 300 mg Tablets is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber.

Drug Label Highlights

Source: This information is taken from the official DailyMed drug label page when available. It is provided for educational purposes and is not a substitute for pharmacist counseling, prescriber instructions, or the full official labeling.

These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS.

ALLOPURINOL tablets, for oral use

Initial U.S. Approval: 1966

Indications And Usage

Allopurinol tablets are xanthine oxidase inhibitor indicated for the management of:

Adult patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) (

Adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels (

Adult patients with recurrent calcium oxlate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (

Limitations of Use

Allopurinol tablets is not recommended for the treatment of asymptomatic hyperuricemia. (

Dosage And Administration

Gout:Prior to initiating treatment assess serum uric acid level, complete blood count, chemistry panel, liver and kidney function tests. Prophylactic treatment for gout flares is recommended. (

2.1,

2.2)

Patients with normal kidney function: Initial dosage is 100 mg orally daily. Increase by 100 mg weekly increments until serum uric acid of 6 mg/dl or less is reached (maximum 800 mg daily). (

2.3)

Patients with impaired kidney function: The initial dosage is 50 mg orally daily. Follow recommendations for titration in patients with renal impairment until target serum uric acid level is reached. (

2.6)

See complete information in the Full Prescribing Information (FPI).

Hyperuricemia Associated with Cancer Therapy:The recommended dosage is:

Adults: 300 mg to 800 mg orally daily.

Pediatric patients: 100 mg/m

2orally every 8 hours to 12 hours (10 mg/kg/day, maximum 800 mg/day)

See complete information in the FPI. (

2.4,

2.6)

Recurrent Calcium Oxalate Calculi:The recommended initial dosage in patients with normal kidney function is 200 mg to 300 mg orally daily. (

2.5)

Dosage in Patients with Renal Impairment: See FPI for dosage modifications in patients with renal impairment. (

2.6)

Dosage Forms And Strengths

Tablets: 100 mg and 300 mg, scored (3)

Contraindications

Known hypersensitivity to allopurinol or to any of the ingredients of allopurinol tablets. (4)

Warnings And Precautions

Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. ( 5.1)
Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. ( 5.2)
Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol tablets. ( 5.3)
Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. ( 5.4)
Myelosuppression: Bone marrow suppression has been reported with allopurinol. ( 5.5)
Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol tablets. ( 5.6)

Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. ( 5.1)
Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. ( 5.2)
Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol tablets. ( 5.3)
Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. ( 5.4)
Myelosuppression: Bone marrow suppression has been reported with allopurinol. ( 5.5)
Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol tablets. ( 5.6)

Skin Rash and Hypersensitivity: Allopurinol has been associated with serious and sometimes fatal dermatological reactions. Discontinue allopurinol tablets at the first appearance of skin rash or other signs of hypersensitivity reaction. (

5.1)

Gout Flares: May occur during initiation of treatment. Concurrent prophylactic treatment with colchicine or anti-inflammatory agents is recommended. (

5.2)

Nephrotoxicity: Allopurinol may affect kidney function. Patients with decreased kidney function require lower doses of allopurinol tablets. (

5.3)

Hepatoxicity: Cases of reversible hepatotoxicity have occurred. If signs and symptoms of hepatotoxicity develop, evaluate liver function. (

5.4)

Myelosuppression: Bone marrow suppression has been reported with allopurinol. (

5.5)

Potential Effect on Driving and Use of Machinery: Drowsiness, somnolence and dizziness have been reported in patients taking allopurinol tablets. (

5.6)

Adverse Reactions

Most common adverse reactions (incidence > 1%) are nausea, diarrhea, and increase in liver function tests. (

To report SUSPECTED ADVERSE REACTIONS, Sun Pharmaceutical Industries, Inc.at 1-800-406-7984or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

Drug Interactions

The following drugs may increase the risk of serious skin reactions: bendamustine, thiazide diuretics, ampicillin and amoxicillin. (

7.1)

Capecitabine: Avoid concomitant use. (

7.2)

Mercaptopurine or Azathioprine: Reduce mercaptopurine or azathioprine dose as recommended in the respective prescribing information. (

7.2)

Pegloticase: Discontinue and refrain from initiating treatment with allopurinol tablets. (

7.2)

See FPI for complete list of significant drug interactions. (

7.2)

Use In Specific Populations

Pregnancy: May cause fetal harm. (

8.1)

Lactation: Advise not to breastfeed. (

8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2024

View Full DailyMed Label View DailyMed PDF

DailyMed highlights last updated: 2026-06-24 22:34:11

Additional information

Size/Count	30 Count
Dose/Strength	300 mg
Form	Tablet

Medication Guide

Official DailyMed Drug Label Information

This product has a DailyMed drug label PDF from the National Library of Medicine.

View / Download PDF View on DailyMed

Source: DailyMed, National Library of Medicine
DailyMed Label: ALLOPURINOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]
Matched NDC: 53489-157-01
Published Date: Mar 05, 2026

Medication Summary

Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.

Overview

Allopurinol tablets are a xanthine oxidase inhibitor used to manage certain adults with gout, adults and pediatric patients receiving cancer therapy that raises uric acid levels, and adults with recurrent calcium oxalate stones linked to high uric acid excretion. They are not recommended for treating asymptomatic hyperuricemia.

The label says to assess baseline labs before starting treatment for gout, and to use prophylaxis for gout flares when therapy begins. Dosing depends on the condition being treated and kidney function, and doses may need to be adjusted carefully in patients with renal impairment.

Important safety warnings include serious skin reactions and hypersensitivity, kidney effects, liver injury, and bone marrow suppression. The label also notes that drowsiness, somnolence, and dizziness can occur, and that certain drugs may interact with allopurinol.

Patients should seek medical attention promptly if they develop a rash or other signs of hypersensitivity, and they should follow the prescriber’s instructions for lab monitoring and dose changes.

Storage Information

STORAGE AND HANDLING Allopurinol tablets, USP are supplied as follows: Allopurinol tablets, 100 mg round, white, scored, debossed MP 71 Bottles of 50 NDC 53489-156-02 Bottles of 100 NDC 53489-156-01 Bottles of 500 NDC 53489-156-05 Bottles of 1000 NDC 53489-156-10 Allopurinol tablets, 300 mg round, orange, scored, debossed MP 80 Bottles of 30 NDC 53489-157-07 Bottles of 50 NDC 53489-157-02 Bottles of 100 NDC 53489-157-01 Bottles of 500 NDC 53489-157-05 Bottles of 1000 NDC 53489-157-10 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) (see USP Controlled Room Temperature).

Key Counseling Points

Take allopurinol exactly as directed by the prescriber.
Baseline blood and urine-related tests may be needed before starting treatment for gout.
Allopurinol may be used to help manage gout, uric acid problems during cancer therapy, or recurrent calcium oxalate stones in certain patients.
A gout flare can happen after starting treatment; the label says prophylaxis may be recommended.
Tell a clinician right away if a rash or other signs of hypersensitivity occur.
The label warns about kidney effects, liver injury, and low blood counts; lab monitoring may be needed.
Drowsiness, somnolence, and dizziness have been reported.
Avoid driving or using dangerous machinery until you know how allopurinol affects you.
Tell the prescriber about all medicines being taken, including capecitabine, azathioprine, mercaptopurine, warfarin, theophylline, and certain antibiotics or diuretics.
Do not use allopurinol for asymptomatic hyperuricemia, per the label.

Helpful Patient Education

Allopurinol tablets are a prescription xanthine oxidase inhibitor used to manage gout, certain cases of high uric acid related to cancer therapy, and recurrent calcium oxalate stones in patients with high uric acid excretion. The label includes dosing considerations for kidney function and advises baseline testing and monitoring for some patients.

This product information also highlights important safety risks, including serious skin reactions, kidney problems, liver injury, and blood count changes. It is intended to help patients and caregivers understand label-based uses, warnings, and counseling points for allopurinol tablets.

Medication Summary last generated: 2026-07-17 02:40:41

Allopurinol 300 mg Tablets --- Generic For Zyloprim --- Sun may require patient-specific counseling based on your prescription, directions, allergies, medical history, and other medications.

This Medication Guide section is provided for general educational purposes only. It does not replace the official medication guide, patient information leaflet, counseling from your pharmacist, or medical advice from your prescriber.

Please read all information provided with your prescription. Contact Pill Pals Pharmacy or your prescriber with questions before using this medication.

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Allopurinol 300 mg Tablets — Generic For Zyloprim — Sun

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