Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu

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
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nightshift Cold and Flu
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
SPL set ID
4592d547-556f-4eec-8faf-6ff9a92e46c8
SPL ID
4ef878df-7224-bd97-e063-6294a90a490b
Version
5
Effective date
2026-04-08
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:08:30

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning (Nightshift Cold & Flu Clear & Cool only): This product contains acetaminophen. Severe liver damage may occur if you take: ■ more than 4000 mg in 24 hours,which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product Allergy alert (Nightshift Cold & Flu Clear & Cool only): 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 (Nightshift Cold & Flu Clear & Cool only): 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. Liver warning (Nightshift Cold & Flu only) This product contains acetaminophen. Severe liver damage may occur if you take: more than 4000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert (Nightshift Cold & Flu only) 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 (Nightshift Cold & Flu only) 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. (Nightshift Cold & Flu only) 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. Ask a doctor before use if you have liver disease (Nightshift Cold & Flu only) heart disease (Fast-Max Severe Congestion & Cough only) high blood pressure (Fast-Max Severe Congestion & Cough only) thyroid disease (Fast-Max Severe Congestion & Cough only) diabetes (Fast-Max Severe Congestion & Cough only) glaucoma (Nightshift Cold & Flu only) trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis (Nightshift Cold & Flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin (Nightshift Cold & Flu only) taking sedatives or tranquilizers (Nightshift Cold & Flu only) When using this product do not use more than directed excitability may occur, especially in children (Nightshift Cold & Flu only) marked drowsiness may occur (Nightshift Cold & Flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nightshift Cold & Flu only) avoid alcoholic drinks (Nightshift Cold & Flu only) use caution when driving a motor vehicle or operating machinery (Nightshift Cold & Flu only) Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days (Nightshift Cold & Flu only) fever gets worse or lasts more than 3 days (Nightshift Cold & Flu only) redness or swelling is present (Nightshift Cold & Flu only) new symptoms occur (Nightshift Cold & Flu only) cough comes back or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Nightshift Cold & Flu only) nervousness, dizziness, or sleeplessness occur (Fast-Max Severe Congestion & Cough only) symptoms do not get better within 7 days or occur with fever (Fast-Max Severe Congestion & Cough only) cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. (Fast-Max Severe Congestion & Cough only) 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 right away. Overdose warning (Nightshift Cold & Flu only) Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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