FDA label 20f392a7-158d-4507-b054-c309642a4bc9

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: 949743a7-f922-4248-aa28-818236c80a67
SPL ID: 20f392a7-158d-4507-b054-c309642a4bc9
Version: 2
Effective date: 2011-08-11
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 01:26:09

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		20f392a7-158d-4507-b054-c309642a4bc9	id
spl set id		949743a7-f922-4248-aa28-818236c80a67	set_id

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions and death. Children: Antihistamines may diminish mental alertness; conversely, particularly in the young child, they may occasionally produce excitation. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents. CNS Depressants: Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Activities Requiring Mental Alertness: Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse reactions which have been reported with the use of antihistamines are as follows: Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness. Central Nervous System: Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity. Integumentary: Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus. Special Senses: Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock. Cardiovascular: Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia. Hematologic: Dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice. Digestive System: Urinary frequency, difficult urination, urinary retention, early menses. Genitourinary: Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Respiratory: Fatigue, chills, headache, increased appetite/weight gain. Miscellaneous:

Reported adverse events (FAERS/openFDA)#

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