FDA label ef4cbbb3-228f-41a3-b0fe-88c5dc9c4935

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
aed2a15b-ffc5-4a7d-aa3f-b4dbcae14346
SPL ID
ef4cbbb3-228f-41a3-b0fe-88c5dc9c4935
Version
1
Effective date
2010-10-28
Source export date
2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:40

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 Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a physician. If symptoms do not improve within 7 days or are accompanied by a fever, consult a physician. Do not take this product, unless directed by a physician, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. Antihistamines should be used with considerable caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Pediatric Use See PRECAUTIONS, Pediatric Use This product may cause excitability especially in children. Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's physician. This product may cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's physician.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Possible side effects of antihistamines are drowsiness, dry mouth, anorexia, nausea, vomiting, headache, dizziness, nervousness, blurred vision, polyuria, heartburn, dysuria, urinary retention and very rarely, dermatitis.

Reported adverse events (FAERS/openFDA)#

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