FDA label f2225ce4-50f0-475b-a203-15d68e991a91

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
0a9e0035-acd4-45ef-8ca5-3bbb66c7035f
SPL ID
f2225ce4-50f0-475b-a203-15d68e991a91
Version
1
Effective date
2020-09-02
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:51

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. Severe liver damage may occur if • adult takes more than 6 doses in 24 hours, which is the maximum daily amount • child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks everyday while using this product. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has • liver disease • is on a sodium-restricted diet. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product: Do not exceed recommended dose Stop use and ask a doctor if: • Pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • new symptoms occur. • 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. Overdose Warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults/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.