FDA label d243bb55-cf55-a1b7-e053-2995a90ac752

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
5f215709-3793-7668-e053-2a91aa0ac332
SPL ID
d243bb55-cf55-a1b7-e053-2995a90ac752
Version
5
Effective date
2021-12-03
Source export date
2026-08-01
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:05:18

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. 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 facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 Do not use with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers Ask a doctor before use if with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers. Ask a doctor or pharmacist before use if you are taking a prescription drug for •anticoagulation (blood thinning) •gout •diabetes •arthritis Stop use and ask a doctor if •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 •pain gets worse or lasts more than 10 days •fever gets worse or lasts more than 3 days •new symptoms occur •ringing in the ears or hearing loss occurs •redness or swelling is present definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.