SEVERE CONGESTION and COUGH MAX

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
SEVERE CONGESTION and COUGH MAX
Generic name
DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL
Manufacturer
AptaPharma Inc.
Product type
HUMAN OTC DRUG
SPL set ID
17a07d2d-f2da-4e51-9a77-6f0c174987bb
SPL ID
1758bfe6-e9c6-445d-9a3c-55c24ba5bde1
Version
1
Effective date
2024-01-31
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:06
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings • Do not use ● 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 ● heart disease ● thyroid disease ● high blood pressure ● diabetes ● trouble urinating due to an enlarged prostate gland ● cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema ● cough that occurs with too much phlegm (mucus) When using this product ● do not use more than directed Stop use and ask a doctor if ●nervousness, dizziness or sleeplessness occur ● symptoms do not get better within 7 days or are accompanied by a fever ● cough comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast feeding , ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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