warnings
WARNINGS: Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions and death. Antihistamines may diminish mental alertness. In young children, they may produce excitation.
FDA label 5886495a-1ef0-4e4c-bd24-32ede3b75f6a
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
- SPL set ID
- ff49f07e-3e9b-4f99-ad47-d9a853014925
- SPL ID
- 5886495a-1ef0-4e4c-bd24-32ede3b75f6a
- Version
- 12
- Effective date
- 2010-12-27
- Source export date
- 2026-10-12
- 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/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:25:42
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 5886495a-1ef0-4e4c-bd24-32ede3b75f6a | id | |
| spl set id | ff49f07e-3e9b-4f99-ad47-d9a853014925 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: The most frequent reactions include drowsiness, lightheadedness, nausea, and dryness of mouth. Less frequently restlessness, nervousness, trembling, or weakness may occur. These side effects need medical attention only if they continue or are bothersome. Those indicating need for immediate medical attention include: CNS depression (severe drowsiness), CNS stimulation (hallucinations, seizures), anticholinergic effects (clumsiness, flushing of the face, shortness of breath, troubled breathing), severe headache, hypertension, or hypotension.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.