GENCONTUSS

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
GENCONTUSS
Generic name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
KRAMER NOVIS
Product type
HUMAN OTC DRUG
SPL set ID
69d16d25-b09b-430e-8e01-0962d840dc21
SPL ID
8a52f9ca-43f9-4f88-ae67-2ee6e1541d51
Version
7
Effective date
2025-12-04
Source export date
2026-09-28
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/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:05:29
Harmonized routes table
Harmonized routes
ORAL

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 : Do not use • to sedate a child or to make a child sleepy. • If you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional condition) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • ​heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • difficulty in urination due to enlargement of the prostate gland • cough that occurs with too much phlegm (mucus) • breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • do not exceed recommended dosage • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • excitability occurs, especially in children • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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