FDA label 56a59810-0fda-4f5e-9ed3-a040756443ed

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
13075fa5-d129-44d7-8860-4daed704ca03
SPL ID
56a59810-0fda-4f5e-9ed3-a040756443ed
Version
7
Effective date
2018-02-23
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:18

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 2 · 7 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: Acetaminophen may cause severe skin reactions. Symptoms may include: ● skin reddening ● blisters ● rash If a skin reaction occurs, stop use and seek medical help right away. Allergy alert Aspirin may cause a severe allergic reaction which may include: ● hives ● facial swelling ● asthma (wheezing) ● shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 2 caplets in 24 hours, which is the maximum daily amount ● with other drugs containing acetaminophen ● 3 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 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 nonprescription 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 Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat. Do Not Use ● if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer ● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if ● you have never had migraines diagnosed by a health professional ● you have a headache that is different from your usual migraines ● you have the worst headache of your life ● you have fever and stiff neck ● you have headaches beginning after or caused by head injury, exertion, coughing or bending ● you experienced your first headache after the age of 50 ● you have daily headaches ● you have a migraine so severe as to require bed rest ● you have liver disease ● 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 asthma ● you have problems or serious side effects from taking pain relievers or fever reducers ● you have vomiting with your migraine headache Ask a doctor or pharmacist before use if you are ● taking a prescription drug for: ● diabetes ● gout ● arthritis ● under a doctor’s care for any serious condition ● taking any other drug ● taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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 ● your migraine is not relieved or worsens after first dose ● new or unexpected symptoms occur ● ringing in the ears or loss of hearing occurs 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

warnings

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ● skin reddening ● blisters ● rash If a skin reaction occurs, stop use and seek medical help right away.

warnings

Allergy alert Aspirin may cause a severe allergic reaction which may include: ● hives ● facial swelling ● asthma (wheezing) ● shock

Reported adverse events (FAERS/openFDA)#

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