FDA label 429e1d97-8180-5664-e063-6294a90aeb2b

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
9a0766dd-3403-471b-8377-ae76b4b6b5a5
SPL ID
429e1d97-8180-5664-e063-6294a90aeb2b
Version
3
Effective date
2025-11-02
Source export date
2026-09-28
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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:44

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 behavior 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 breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.