FDA label 4264e171-e01a-8832-e063-6294a90ad688

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
7ac8768f-129f-4ad5-86d9-6eaa74ffb1d7
SPL ID
4264e171-e01a-8832-e063-6294a90ad688
Version
5
Effective date
2025-10-30
Source export date
2026-08-01
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:01:27

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you: • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) • have 3 or more alcoholic drinks every day while using this product • have stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • take more or for a longer time than directed Do not use: • if you are on a sodium restricted diet • if you are allergic to salicylates (including aspirin) unless directed by a doctor • if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor Ask a doctor before use if you have • frequent, burning urination for the first time • the stomach bleeding warning applying to you • history of stomach problems, such as heartburn • high blood pressure • heart disease • liver cirrhosis • bleeding problems • diuretic use • ulcers • kidney disease • reached age 60 or older Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant), steroid, diabetes, gout or arthritis drug When using this product • do not take more than the recommended dosage Stop and ask a doctor if • product has been used for 3 days • you experience any of the following signs of stomach bleeding: • feel faint, vomit blood • have bloody or black stools • have stomach pain that does not get better • ringing in the ears or a loss of hearing occurs If pregnant or breast feeding, ask a health professional before use.