FDA label f44f322f-c170-1d60-e053-2995a90aff57

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
f03f43af-4db8-4b61-8371-6b6d8ce71712
SPL ID
f44f322f-c170-1d60-e053-2995a90aff57
Version
6
Effective date
2023-02-09
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 23:03:50

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) Aspirin may cause a severe allergic reaction, which may include the following, Hives Facial swelling Shock Asthma (Wheezing) Allergy Alert (Acetaminophen) Acetaminophen may cause severe skin reactions. Symptoms may include the following, Blisters Rash Skin reddening If a skin reaction does occur, stop use and seek medical help right away. Liver Warning This product contains acetaminophen. Severe liver damage may occur if you take the following, More than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount With other drugs containing acetaminophen Three or more alcoholic drinks every day while using this product Stomach Bleeding Warning This product contains an NSAID, which may cause severe stomach bleeding. The chance of severe stomach bleeding is higher if you Are age 60 or older Have 3 or more alcoholic drinks every day while using this product Take more than directed, or for a longer time than directed Take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen or others] Have had stomach ulcers or bleeding problems Take a blood thinning (anticoagulant) or steroid drug Do Not Use Do not use this product in the following scenarios, If you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer With any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. With other products containing diphenhydramine, including any used externally In children under 12 years of age Ask a Doctor Ask a doctor before using this product if, The stomach bleeding warning applies to you You have a history of stomach problems, such as heartburn You have difficulty in urination due to enlargement of the prostate gland You have liver disease You have high blood pressure, heart disease, liver cirrhosis or kidney disease You have glaucoma You are taking a diuretic You have asthma You have a breathing problem such as emphysema or chronic bronchitis Ask a Doctor or a Pharmacist Ask a doctor or pharmacist before using this product if you are taking the following, A prescription drug for: + Arthritis + Diabetes + Gout Sedatives or Tranquilizers Any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer Any other drug, or are under a doctor's care for any serious condition When using this product, Do not drive a motor vehicle or operate machinery Drowsiness may occur Avoid alcoholic beverages Stop Use and ask a Doctor Stop use of this product and ask a Doctor in the event of the following, If an allergic reaction occurs. Seek medical help right away. You experience any of signs of stomach bleeding, such as + Feeling faint + Vomit blood + Have bloody or black stools + Have stomach pain that does not get better New symptoms occur Redness or swelling is present Ringing in the ears or loss of hearing occurs Your pain gets worse or lasts for more than 10 days Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. These could be signs of a serious condition Pregnancy and Nursing Mothers If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin 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 an overdose, seek medical help right away or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.