FDA label db716e81-c957-4723-b0c4-2c915fd60b51

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
a3d7e991-567b-4542-96f7-e3d10c92a4eb
SPL ID
db716e81-c957-4723-b0c4-2c915fd60b51
Version
2
Effective date
2017-06-27
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 02:22:59

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. Sever liver damage may occur if your child takes: more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. 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 products containing acetaminophen, decongestants or cough suppressants (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist before using with other drugs. Drug Interaction Precaution: Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has liver, heart or thyroid disease high blood pressure or diabetes a cough accompanied by excessive phlegm (mucus) or has a persistent or chronic cough such as occurs with asthma When using this product: DO NOT EXCEEED RECOMMENDED DOSAGE. Stop use and ask a doctor if your child becomes nervous, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain, cough or nasal congestion gets worse or lasts more than 5 days cough tends to recur or is accompanied by high fever, rash or persistent headaches redness or swelling is present. These could be signs of a serious condition. Keep out of the reach of children.

Reported adverse events (FAERS/openFDA)#

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