Tolmetindrug info

tolmetin 400 MG Oral Capsule

What it is used for

Carefully consider the potential benefits and risks of TOLECTIN capsules, USP and other treatment options before deciding to use TOLECTIN capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. TOLECTIN capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of TOLECTIN capsules have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION ).

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 22, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Each capsule for oral administration contains 492 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The empty gelatin capsule shells contain FD&C Blue No. 1, gelatin, and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze. The pKa of tolmetin is 3.5 and TOLECTIN is freely soluble in water, soluble in methanol and slightly soluble in alcohol. TOLECTIN is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is: (C 15 H 14 NNaO 3

2H 2 O) Sodium 1-methyl-5 p -toluoylpyrrole-2-acetate dihydrate. "Image Description"

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 22, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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