DOMETUSS

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
DOMETUSS
Generic name
CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
Domel Laboratories
Product type
HUMAN OTC DRUG
SPL set ID
3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe
SPL ID
897f949d-5437-4419-a6c3-206778dbf45d
Version
4
Effective date
2025-09-16
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:56:57
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 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 heart disease thyroid disease trouble urinating due to enlarged prostate gland glaucoma cough that occurs with too much phlegm(mucus) a breathing problems 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 may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may cause increased drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially with children. STOP USE AND ASK A DOCTOR IF you get nervous, dizzy, or sleepless. cough last more than 7 days, comes back, or is accompanied by fever, rash or persitent headaches. 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 . In case of accidental overdose, get medical help or contact a poison control Center right away.

Reported adverse events (FAERS/openFDA)#

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