FDA label 9e54cbcc-5107-48f9-b080-fe41dba93472
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
- 74b92bdf-5447-4932-a265-39891a4557a4
- SPL ID
- 9e54cbcc-5107-48f9-b080-fe41dba93472
- Version
- 2
- Effective date
- 2013-04-24
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:47:26
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 | 9e54cbcc-5107-48f9-b080-fe41dba93472 | id | |
| spl set id | 74b92bdf-5447-4932-a265-39891a4557a4 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Caution should be exercised in patients with hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. Patients sixty (60) years and older may demonstrate an increased response to this drug, both in therapeutic effect and in the incidence of adverse reactions. A reduction in dosage may be more appropriate for these patients. Antihistamines may cause drowsiness or excitability, particularly in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The physician should be alert to the possibility of any of the adverse reactions which have been observed with antihistaminic drugs. These include: drowsiness; confusion; restlessness; nausea; vomiting; drug rash; vertigo; palpitation; anorexia; dizziness; dysuria due to vesicle sphincter spasm; headache, insomnia; anxiety; tension; weakness; tachycardia; angina; sweating; blood pressure elevation; mydriasis; gastric distress; abdominal cramps; central nervous system stimulation; circulatory collapse.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.