FDA label 627cbe02-0c2e-41ef-a26f-6fb7dce0c13f

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
7369cf7e-b1b8-4faf-982c-454e2ae6cbfa
SPL ID
627cbe02-0c2e-41ef-a26f-6fb7dce0c13f
Version
1
Effective date
2015-04-07
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:34:34

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

Uses: temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis • muscle pain • pain and fever of colds • toothache • temporarily reduces fever 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 nonsteroidal anti-inflammatory drugs (NSAIDs), 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 prescription or nonprescription containing an NSAID [aspirin, ibuprofen, naproxen, or others] • take more or for a longer time than directed. Do not use: • if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if: • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug for: • gout • diabetes • arthritis Stop use and ask a doctor if: • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • you feel faint, vomit blood, or have bloody or black stools • redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts more than 3 days • new symptoms occur • ringing in the ears or a loss of hearing occurs

Reported adverse events (FAERS/openFDA)#

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