Available Dosage Forms and Strengths

Caplets — 200 mg

Oral suspension — 100 mg per 5-ml teaspoonful

Tablets — 200 mg, 300 mg, 400 mg, 600 mg, 800 mg

Usual Adult Dosage Range: 200 to 800 mg 3 or 4 times/day. Total daily dosage should not exceed 3200 mg (3600 mg in selected individuals). Note: Actual dosage and administration schedulemust be deter­mined by the physician for each patient individually.

Dosing Instructions: Take either on an empty stomach or with food or milk to prevent stomach irritation. Take with a full glass of water and re­main upright (do not lie down) for 30 minutes. The tablet may be crushed for administration.

Usual Duration of Use: Continual use on a regular schedule for 1 to 2 weeks is usually necessary to determine this drug's effectiveness in relieving the discomfort of arthritis. Long-term use requires supervision and periodic evaluation by the physician. Consult your physician on a regu­lar basis.

This Drug Should Not Be Taken If

• you have had an allergic reaction to it previously.

• you are subject to asthma or nasal polyps caused by aspirin.

• you have active peptic ulcer disease or any form of gastrointestinal
bleeding.

• you have a bleeding disorder or a blood cell disorder.

• you have severe impairment of kidney function.

Inform Your Physician Before Taking This Drug If

• you are allergic to aspirin or to other aspirin substitutes.

• you have a history of peptic ulcer disease or any type of bleeding
disorder.

• you have impaired liver or kidney function.

• you have high blood pressure or a history of heart failure.

• you are taking any of the following: acetaminophen, aspirin or other
aspirin substitutes, anticoagulants, oral antidiabetic drugs.

Possible Side-Effects (natural, expected and unavoidable drug actions) Fluid retention (weight gain); pink, red, purple or rust coloration of urine (of no significance).

Possible Adverse Effects(unusual, unexpected and infrequent reactions) If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reactions: Skin rash, hives, itching.

Headache, dizziness, altered or blurred vision, ringing in the ears, depres­sion.

Mouth sores, indigestion, nausea, vomiting, constipation, diarrhea. Serious Adverse Effects

Allergic Reactions: Anaphylaxis, severe skin reactions.

Idiosyncratic Reactions: Drug-induced meningitis with fever and coma.

Active peptic ulcer, with or without bleeding.

Liver damage with jaundice.

Kidney damage with painful urination, bloody urine, reduced urine for­mation.

Rare bone marrow depression - fatigue, weakness, fever, sore throat, abnormal bleeding or bruising.