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FDA label cd5d2717-555a-4b9e-9231-20bf67f17337

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
47625688-0684-4c63-945d-9398da43a4fc
SPL ID
cd5d2717-555a-4b9e-9231-20bf67f17337
Version
3
Effective date
2016-08-06
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:00:58

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 young children, may producehallucinations, central nervous system depression, convulsions, respiratory and cardiac arrest, and death. Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. Pediatric Patients: 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. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. (see ). Activities Requiring Mental Alertness: PRECAUTIONS, Geriatric Use

Adverse reactions cross-check#

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

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: Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, 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.