FDA label 06c1f8c3-9673-3c2c-e063-6294a90a50a2

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
8ce93565-cf00-4a50-a1f4-0c430219bf15
SPL ID
06c1f8c3-9673-3c2c-e063-6294a90a50a2
Version
4
Effective date
2023-10-02
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:19:58

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 12 caplets in 24 hours, which is the maximum daily amount with other drugs that contain acetaminophen 3 or more alcoholic drinks daily 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 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 drug containing diphenhydramine, even one used on the skin (Mucinex FAST-MAX NIGHT TIME 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. for children under 12 years of age 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 glaucoma (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) a breathing problem such as emphysema or chronic bronchitis (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Mucinex FAST-MAX DAY TIME Severe Cold only) cough that occurs with too much phlegm (mucus) (Mucinex FAST-MAX DAY TIME Severe Cold only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) When using this product do not use more than directed excitability may occur, especially in children (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) marked drowsiness may occur (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) alcohol, sedatives, and tranquilizers may increase drowsiness (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) avoid alcoholic drinks (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) be careful when driving a motor vehicle or operating machinery (Mucinex FAST-MAX NIGHT TIME Cold & Flu only) Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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 cough comes back, or occurs with fever, rash, or headache that lasts. These could be a sign of a serious condition. (Mucinex FAST-MAX DAY TIME Severe Cold only) If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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.