FDA label e2cb359d-1c44-4a31-8675-89a15343c4c3

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
2a3420aa-4dea-407b-8168-da77110782c6
SPL ID
e2cb359d-1c44-4a31-8675-89a15343c4c3
Version
4
Effective date
2019-11-04
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:49

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 Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: 1. adult takes more than 4,000 mg of acetaminophen in 24 hours 2. child takes more than 5 doses in 24 hours, which is the maximum daily amount 3. taken with other drugs containing acetaminophen 4. adult has 3 or more alcoholic drinks every day while using this product. Do not use 1. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 2. if you are allergic to acetaminophen or any of the inactive ingredients in this product Stop use and ask a doctor if 1. pain gets worse or lasts more than 10 days in adults 2. pain gets worse or lasts more than 5 days in children under 12 years 3. fever gets worse or lasts more than 3 days 4. new symptoms occur 5. redness or swelling is present 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. Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user is taking blood thinning drug warfarin. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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