FDA label 31fe4b5d-bdbe-4366-b4b6-85fb0b4dba30

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
42593c25-244f-44bb-a783-65608f9ab891
SPL ID
31fe4b5d-bdbe-4366-b4b6-85fb0b4dba30
Version
3
Effective date
2010-06-11
Source export date
2026-10-22
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-22/1efc345682dd2c7d09122ceeaeceedc25aaee91e2e580bbcb238c97f7d29f85b/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 01:09:25

Warnings cross-check#

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

Warnings sections page 2 of 2 · 8 matching rows.

warnings

Warnings: For external use only.

warnings

Warnings: For external use only. Avoid contact with eyes. If this happens, rinse thoroughly with water.

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. When using 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 a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.

warnings

Warnings: For external use only Flammable, keep away from fire or flame

Reported adverse events (FAERS/openFDA)#

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