FDA label 3b3a1206-ce90-4ec2-8841-cbcca14fe4c0

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
2bd23639-0faf-4386-9dc4-446ff6cc5ba1
SPL ID
3b3a1206-ce90-4ec2-8841-cbcca14fe4c0
Version
2
Effective date
2017-03-16
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:15

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 Warnings: 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. Caution if taken 1) Keep direction 2) Not taken with anti-tussive, expectorant, antipyretic, antihistamine, sedative 3) Let children take drug by protector 4) In infants younger than 3 months to avoid taking more than three months also infant under 2 years of age to be a doctor, and if it is not needed is not to take your medicine Administered to infants younger than 2 years if the drug should be carefully monitored for parents to know Caution if taken 1) While taking a rash, redness, nausea, vomiting, constipation, anorexia, dysuria, dizziness and other symptoms when you stop asking your doctor or pharmacist 2) Stop taking medicine and ask a doctor or pharmacist before use even though adverse events are rarely reported below. - Rash, edema, breast burden, pale complexion, cold hand and foot, cold sweat, shortness of breath - High fever, rash, flare, bubble on whole skin, mouth, eye mucosa - Asthma 3) Barbital induced drug, tri-cyclic antidepressant and alcohol can reduce ability of acetaminophen metabolism and increase plasma half life. Alcohol could increase liver toxicity of acetaminophen overdose 4) If you get drowsy, Be careful when driving a motor vehicle or operating machinery 5) Please don’t take drug and ask doctor or pharmacist if you can not feel better by several dose. 6) Don’t take for a long term

Reported adverse events (FAERS/openFDA)#

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