FDA label 09556adf-6925-42ee-9f1a-4a6f30932151

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
49d877ee-7bd8-42dc-907e-57519dea4a9a
SPL ID
09556adf-6925-42ee-9f1a-4a6f30932151
Version
3
Effective date
2021-11-15
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 01:30:26

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: These products contain acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • with any other product containing diphenhydramine, even one used on skin (SINUS RELIEF Night only) • 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 these products. • if you have ever had an allergic reaction to these products or any of their ingredients Ask a doctor before use if you have • liver disease • heart disease • diabetes • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • glaucoma (SINUS RELIEF Night only) • a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only) • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only) • cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only) Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers (SINUS RELIEF Night only) When using these products • do not use more than directed • excitability may occur, especially in children (SINUS RELIEF Night only) • marked drowsiness may occur (SINUS RELIEF Night only) • alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS RELIEF Night only) • avoid alcoholic drinks (SINUS RELIEF Night only) • be careful when driving a motor vehicle or operating machinery (SINUS RELIEF Night only) Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, cough or nasal congestion gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only) If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.