FDA label f9f5cdc9-9fe1-4875-b18b-0388bf86af7c

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
a9eca15f-46db-489e-b2b3-c583785cb1e4
SPL ID
f9f5cdc9-9fe1-4875-b18b-0388bf86af7c
Version
5
Effective date
2021-07-14
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:11:45

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. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening 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 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) if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only) with any other product containing diphenhydramine, even one used on skin (Nighttime only) Ask a doctor before use if you have heart disease diabetes thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure difficulty in urination due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis Nighttime only) glaucoma (Nighttime only) liver disease (Nighttime only) Ask a doctor or pharmacist before use if you are (Nighttime only) taking the blood thinning drug warfarin taking sedatives or tranquilizer When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) be careful when driving a motor vehicle or operating machinery (Nighttime only) avoid alcoholic beverages (Nighttime only) marked drowsiness may occur (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) redness or swelling is present (Nighttime only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only) new symptoms occur (Nighttime only) fever gets worse or lasts more than 3 days (Nighttime only) 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 professional before use. Keep out of reach of children. In case of accidental 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. If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.