FDA label 33371cb9-9cec-44bd-b2d8-68fb1bc8c6bf

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
c47d3763-0216-47bb-bc43-642e11bfa44c
SPL ID
33371cb9-9cec-44bd-b2d8-68fb1bc8c6bf
Version
8
Effective date
2020-08-28
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:05

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 (Nighttime only) Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 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 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only) with any other product containing diphenhydramine, even one used on skin (Nighttime only) if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only) Ask a doctor before use if you have heart disease liver disease (Nighttime only) diabetes thyroid disease (Nighttime only) glaucoma high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) (Daytime only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only) a breathing problem such as emphysema or chronic bronchitis (Nighttime only) Ask a doctor or pharmacist before use if you are (Nighttime only) taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic drinks (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever (Daytime only) persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache (Daytime only) redness or swelling is present (Nighttime only) pain or nasal congestion gets worse or lasts more than 7 days (Nighttime only) fever gets worse or lasts more than 3 days (Nighttime only) new symptoms occur (Nighttime only) These could be signs of a serious condition. 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 (1-800-222-1222) right away. If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.

Reported adverse events (FAERS/openFDA)#

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