FDA label 973da92c-a2da-e173-e053-2995a90a0455

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
973da92c-a2d9-e173-e053-2995a90a0455
SPL ID
973da92c-a2da-e173-e053-2995a90a0455
Version
1
Effective date
2019-11-13
Source export date
2026-08-01
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/2026-08-01/928e480b2a9ec5fd356ebc3e5dcca70f0f57b8a051cfbb174a4421de39bb77a2/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:25:26

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 an NSAID, which may cuase severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach uclers or bleeding problems take a blood thinning (anticoagulant) or sterioid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen naproxen, or others) have 3 or more alcoholic drinks every day while using the product 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 if you have ever had an allergic reaction to this product or any of its ingredients 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 diueretic you have asthma you have a sodium-restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs taking a prescription drug for diabetes, gout, or arthritis When using this product do not exceed recommended dosage 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 feel faint vomit blood have bloody or black stools have stomach pain that does not get better symptoms get worse or last more than 10 days redness or swelling is present ringing in the ears or a loss of hearing occurs new symptoms occur If pregnant or breast-feeding , ask a health professional before us. It is especially important not to use aspirin during the last 3 months of pregnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complicaitons during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.