Sudafed Sinus Congestion plus Cold Severe Day and Night

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)

Brand name
Sudafed Sinus Congestion plus Cold Severe Day and Night
Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE, PSEUDOEPHEDRINE
Manufacturer
Kenvue Brands LLC
Product type
HUMAN OTC DRUG
SPL set ID
5382dcad-0337-4440-e063-6394a90a706e
SPL ID
5382e4cc-3fc5-359e-e063-6394a90a169b
Version
1
Effective date
2026-06-10
Source export date
2026-09-28
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/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:36:36
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

​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 Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain or nasal congestion gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur 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.

warnings

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. ■ with any other product containing diphenhydramine, even one used on skin ■ 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 Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ glaucoma Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not exceed recommended dose ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives and tranquilizers may increase drowsiness ■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occur ■ pain or nasal congestion gets worse or lasts more than 7 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur 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.

Reported adverse events (FAERS/openFDA)#

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