FDA label 9179677b-e4e2-4cdf-beee-f9dd23e0f360

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
df8b3625-8c82-4ab8-9428-26809fbd99ed
SPL ID
9179677b-e4e2-4cdf-beee-f9dd23e0f360
Version
11
Effective date
2021-11-02
Source export date
2026-08-01
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/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:02:33

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: This product contains 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 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. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy (Nighttime only) Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) liver disease difficulty in urination due to enlargement of the prostate gland heart disease (Daytime only) diabetes (Daytime only) thyroid disease (Daytime only) high blood pressure (Daytime only) persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only) glaucoma (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) avoid alcoholic beverages (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (Daytime only) pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only) pain or cough gets worse or lasts more than 7 days (Nighttime only) 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 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. Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.