FDA label 9871f8a8-da4a-4b65-8894-31155083b466

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
aa264ce6-41a0-4099-86c7-5fcdc1bb9da3
SPL ID
9871f8a8-da4a-4b65-8894-31155083b466
Version
1
Effective date
2018-06-28
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:56

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. ▪ with any other drug containing diphenhydramine, even one used on the skin ▪ 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. ▪ 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, thyroid disease, or glaucoma ▪ you have a cough with excessive phlegm (mucus) ▪ you have difficulty in urination due to enlargement of the prostate gland ▪ you have breathing problems such as emphysema or chronic bronchitis ▪ you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are ▪ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout, or arthritis. ▪ taking a diuretic ▪ under a doctor’s care for any serious condition ▪ taking sedatives or tranquilizers When using this product ▪ do not use more than directed ▪ excitability may occur, especially in children ▪ marked drowsiness may occur ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ avoid alcoholic drinks ▪ be careful when driving a motor vehicle or operating machinery 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 (NSAIDs) 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.