FDA label ea0bd1b8-e21c-4cc8-97af-bf995da26a7f

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
f540b4e7-ba66-48d0-93a9-eb9ad3f55e67
SPL ID
ea0bd1b8-e21c-4cc8-97af-bf995da26a7f
Version
2
Effective date
2017-11-03
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:12:28

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 12 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using these products 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. • 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. • to make a child sleepy Ask a doctor before use if you have • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis (Nighttime Sinus only) • glaucoma (Nighttime Sinus only) Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using these products • do not use more than directed In addition, when using Nighttime Sinus: • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if • redness or swelling is present • pain or nasal congestion gets worse or lasts more than 7 days • you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days • new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. 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.