FDA label dc792803-726f-f48d-e053-2a95a90a7369

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
7a027fdf-a69a-9cbf-e053-2a91aa0ac4d6
SPL ID
dc792803-726f-f48d-e053-2a95a90a7369
Version
3
Effective date
2022-04-12
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:49:32

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

Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take: *more than 4 doses in 24 hrs, which is the maximum daily amount for this product * with other drugs containing acetaminophen *3 or more alcoholic drinks every day while using this product 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. 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 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 sleep (Nighttime only). Ask a doctor before use if you have * liver disease * heart disease (Daytime only) * high blood pressure (Daytime only) * thyroid disease (Daytime only) * trouble urinating due to an enlarged prostate gland * glaucoma (Nighttime only) * persistent or chronic cough such as occurs with smoking, asthma or emphysema and (Nighttime only) chronic bronchitis * cough that occurs with too much phlegm (mucus) Ask a doctor or a pharmacist before use if you are * taking the blood thinning drug warfarin * taking sedatives or tranquilizers (Nighttime only) When using this product Do not use more than directed. In addition when using Nighttime: * excitability may occur, especially in children * marked drowsiness may occur * alcohol, sedatives, and tranquilizers may increase drowsiness * be careful when driving a motor vehicle or operating machinery * avoid alcoholic drinks Stop use and ask a doctor if * you get nervous, dizzy, or sleepless (Daytime only) * pain, cough and nasal congestion (Daytime only) may get worse or lasts more than 7 days * new symptoms occur * fever gets worse or lasts more than 3 days * redness or swelling is present * cough comes back or occurs with 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 OVERDOSE WARNING: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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