Maximum strength Max Cold and Sinus

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
Maximum strength Max Cold and Sinus
Generic name
ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
AptaPharma Inc.
Product type
HUMAN OTC DRUG
SPL set ID
263dae13-5f92-4505-8bcc-e903d05b9a0c
SPL ID
ca73e55a-9cf6-4629-9e2d-2c2c9f328ad2
Version
1
Effective date
2024-01-31
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:51
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 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. • for children under 12 years of age Ask a doctor before use if you have • liver disease • heart disease • thyroid disease • high blood pressure • diabetes • trouble urinating due to an enlarged prostate gland • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma 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 • redness or swelling is present • symptoms do not get better within 7 days or are accompanied by a fever • fever gets worse or lasts more than 3 days • new symptoms occur • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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