CVS Maximum Strength Cold and Flu Relief

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
CVS Maximum Strength Cold and Flu Relief
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL
Manufacturer
CVS PHARMACY
Product type
HUMAN OTC DRUG
SPL set ID
e1c246a4-7a8c-4761-ab26-13b5165029cc
SPL ID
bc659301-706a-4c57-9b83-32a44f0cb320
Version
10
Effective date
2026-08-19
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:16:47
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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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 6 doses in 24 hours, which is the maximum daily amount ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks daily while using this product Generic Section Allergy alert : Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin ▪ 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. ▪ for children under 12 years of age ▪ 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 ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ 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 When using this product do not use more than directed 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 rash, or persistent headache. 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.