FDA label 150b7e3b-5073-45f9-b2bb-b4ce0f618726

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
231eac6c-a601-4c64-b1ce-2236ba0acde6
SPL ID
150b7e3b-5073-45f9-b2bb-b4ce0f618726
Version
4
Effective date
2017-12-19
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:35:29

Warnings cross-check#

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

Warnings sections page 1 of 1 · 4 matching rows.

warnings

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. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 6 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 Caffeine warning: Commended 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 heartbeat. Do Not Use ● if you are allergic to acetaminophen ● 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 us if ● you have liver disease Ask a doctor or pharmacist before use if you are ● taking the blood thinning drug warfarin Stop use and ask a doctor if ● any new symptoms occur ● painful area is red or swollen ● pain gets worse or lasts for more than 10 days ● fever gets worse or lasts for more than 3 days These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. 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

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 6 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

warnings

Caffeine warning: Commended 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 heartbeat.

Reported adverse events (FAERS/openFDA)#

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