FDA label d4a4b843-b48a-42e9-a711-396d2d41b7c5

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
34a32f67-31a0-487d-e054-00144ff88e88
SPL ID
d4a4b843-b48a-42e9-a711-396d2d41b7c5
Version
3
Effective date
2019-11-18
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:50:34

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

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 Salicylates (NSAIDs) may cause a severe allergic reaction which may include: ▪ hives ▪ rash ▪ shock ▪ skin reddening ▪ facial swelling ▪ asthma (wheezing) Stomach bleeding warnings 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 non-prescription 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 Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use ▪ if you have ever had an allergic reaction to salicylates (including aspirin) or any other pain reliever/ fever reducer. ▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ▪ if you have ever had an allergic reaction to this product or any of its ingredients ▪ in children under 12 years of age Ask a doctor before use if ▪ stomach bleeding warning applies to you ▪ you have a history of stomach problems, such as heartburn or if you have ulcers or bleeding problems ▪ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, diabetes or thyroid disease ▪ you have a cough with excessive phlegm (mucus) ▪ you have difficulty in urination due to enlargement of the prostate gland ▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ▪ you have asthma Ask a doctor or pharmacist before use if you are ▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis. ▪ under a doctor’s care for any serious condition ▪you are taking a diuretic 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. ▪ pain, cough, or nasal congestion gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ ringing in the ears or a loss of hearing occurs ▪ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occurs ▪ 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use salicylates (NSAID) during the last 3 months of pregnancy unless 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.

Reported adverse events (FAERS/openFDA)#

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