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FDA label f62c37b2-e069-4fdb-bf08-473026fe74cf

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
8ee3630a-4858-4739-a26e-05f8400cda2e
SPL ID
f62c37b2-e069-4fdb-bf08-473026fe74cf
Version
11
Effective date
2010-12-29
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:40:20

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Antihistamines may diminish mental alertness, and may cause hyperexcitability especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Use with caution in patients with hypertension, ischemic heart disease, and persons older than 60 years old. Do not give this product to children who have a chronic pulmonary disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives or tranquilizers without first consulting with a doctor. Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The most frequent adverse reactions to Brompheniramine Maleate 1 mg Drops include: sedation, dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic- urticaria, drug rash, photosensitivity, pruritus Cardiovascular System- hypotension, hypertension, cardiac arrhythmias, palpitations Central Nervous System (CNS)- disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria. G.U. System- urinary frequency, difficult urination. G.I. System- epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System- tightness of chest and wheezing, shortness of breath. Hematologic System- hemolytic anemia, thrombocytopenia, agranulocytosis.

Reported adverse events (FAERS/openFDA)#

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