FDA label 0075197c-6d37-46ca-be07-38935b21cb80
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
- f705ff57-2dcb-4a1b-9871-9ab453852570
- SPL ID
- 0075197c-6d37-46ca-be07-38935b21cb80
- Version
- 2
- Effective date
- 2017-03-07
- 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 02:20:57
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 | 0075197c-6d37-46ca-be07-38935b21cb80 | id | |
| spl set id | f705ff57-2dcb-4a1b-9871-9ab453852570 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
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 you take • more than 6 packets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day 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 • in a child under 4 years of age • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, as a doctor or a pharmacist. • with any other product containing diphenhydramine, even one used on the skin if you are now 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask Doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • a sodium restricted diet • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema, asthma or chronic bronchitis • cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are taking • sedatives or tranquilizers the blood thinning drug warfarin When using this product • do not exceed recommended dosage • avoid alcoholic drinks • marked drowsiness may occur • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • symptoms do not get better or worsen • pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health care professional before use. 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.