FDA label 6dda46cb-fca6-f97f-e053-2991aa0afa1e

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
960f26d1-159c-41ea-a42f-b92936880874
SPL ID
6dda46cb-fca6-f97f-e053-2991aa0afa1e
Version
2
Effective date
2018-06-04
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:37:34

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •asthma (wheezing) •facial swelling •shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you •are age 60 or older •have had stomach ulcers or bleeding problems •take a blood thinning (anticoagulant) or steroid drug •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 •take more or for a longer time than directed

warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •asthma (wheezing) •facial swelling •shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you •are age 60 or older •have had stomach ulcers or bleeding problems •take a blood thinning (anticoagulant) or steroid drug •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 •take more or for a longer time than directed

Reported adverse events (FAERS/openFDA)#

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