boxed warning
TAMPER-EVIDENT FEATURE: DO NOT USE IF SAFETY SEAL PRINTED WITH “TRIAMINIC” AROUND BOTTLE CAP IS BROKEN OR MISSING.
FDA label 20ffbf63-2f25-4ef8-8bf2-6a7dc392f86c
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
- SPL set ID
- 56564534-8ff7-43e3-87d4-b55269aca004
- SPL ID
- 20ffbf63-2f25-4ef8-8bf2-6a7dc392f86c
- Version
- 2
- Effective date
- 2016-10-12
- Source export date
- 2026-09-28
- 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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:59:39
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 20ffbf63-2f25-4ef8-8bf2-6a7dc392f86c | id | |
| spl set id | 56564534-8ff7-43e3-87d4-b55269aca004 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child take • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen 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 • if your child is allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask 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 When using this product do not exceed recommended dosage 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 • redness or swelling is present new symptoms occur Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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.