Home FDA labels 651bbf83-f1c9-4cfd-80d0-cb9f44a00c2f FDA label 651bbf83-f1c9-4cfd-80d0-cb9f44a00c2f 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)
SPL set ID 2ff4bd27-ebed-48a2-849a-15dec7b0b590
SPL ID 651bbf83-f1c9-4cfd-80d0-cb9f44a00c2f
Version 5
Effective date 2009-12-10
Source export date 2026-10-12
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:49:57 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
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: Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma, or prostatic hypertrophy. Do not use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI. Antihistamines should be used with considerable caution in patients with narrowangle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions Adverse Reactions: The most frequent adverse reactions are underscored. 1. General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat. 2. Cardiovascular System: Hypotension, headache, palpitations, tachycardia and extrasystoles. 3. Hematologic System : Hemolytic anemia, thrombocytopenia and agranulocytosis. 4. Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, neuritis, convulsions. 5. GI System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. 6. GU System: Urinary frequency, difficult urination, urinary retention, early menses. 7. Respiratory System : Thickening of bronchial secretions, tightness of chest or throat and wheezing, nasal stuffiness. Serious side effects with oral antihistamines or sympathomimetics have been rare.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.