FDA label cf35d34f-cf02-46b1-84db-d9e3d7782d89

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
6b91e8d9-445a-45dc-a096-aaa7b4c7824c
SPL ID
cf35d34f-cf02-46b1-84db-d9e3d7782d89
Version
9
Effective date
2010-11-15
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:51:19

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The most common effects associated with antihistamines have been drowsiness sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare. Other adverse reactions may include: Dermatologic – urticaria, drug rash, photosensitivity, pruritus. Cardiovascular – hypotension, hypertension, cardiac arrhythmias, palpitations. Central Nervous Systems (CNS) – disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria. Genitourinary – urinary frequency, difficult urination. Gastrointestinal – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory – tightness of the chest and wheezing, shortness of breath. Hematologic – hemolytic anemia, thrombocytopenia, agranulocytosis.

Reported adverse events (FAERS/openFDA)#

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