FDA label c7a9e305-6bbf-4096-90c4-b11bd6b58851

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
7c06e884-ccbf-441b-a8a0-ef25e2bad5df
SPL ID
c7a9e305-6bbf-4096-90c4-b11bd6b58851
Version
2
Effective date
2017-03-17
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:48

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 Caution: 1. Warning Ask a doctor or pharmacist before use if you are regularly drinking over three cups of alcohol per day or taking any other antipyretic and analgesics. Liver can be damaged if taken 2. Contraindication 1) If you are anaphylactic to this drug (e.g., rash, flare, pruritis, edema) 2) Asthma patient after taking this drug or other anti-cold, antipyretic and analgesic. 3. Ask a doctor or pharmacist before use 1) Anaphylactic history including family 2) Disease of Liver, kidney and thyroid disease, Diabetes, hypertension, weakling, high-fever 3) Heart failure, elderly 4) Pregnant or breast-feeding 4. Caution if taken 1) Anti-tussive, expectorant, other anti-cold, antipyretic, analgesic, antihistamine, sedative could not be taken simultaneously 2) Be careful when driving a motor vehicle or operating machinery. Successive application is prohibited for a long term 3) Ask a doctor or pharmacist before use even though adverse events are rarely reported below. (1) Rash, edema, breast burden, pale complexion, cold hand and foot, cold sweat, shortness of breath (2) High fever, rash, flare, bubble on whole skin, mouth, eye mucosa (3) Asthma 4) Barbital induced drug, tri-cyclic antidepressant and alcohol can reduce ability of acetaminophen metabolism and increase plasma half life. Alcohol can increase liver toxicity of acetaminophen overdose 5. Adverse events : rash, flare, nausea, vomiting, loss of appetite, dizziness. 6. Et cetera Keep out of reach of children. Avoid sunlight and keep in cool and low humid place.

Reported adverse events (FAERS/openFDA)#

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