FDA label 8141c768-3d60-455b-a046-f87dc14868bf
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
- SPL set ID
- 9dbc6d1a-8612-41ed-8560-8ba50733e0ea
- SPL ID
- 8141c768-3d60-455b-a046-f87dc14868bf
- Version
- 1
- Effective date
- 2018-05-22
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:29:22
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 8141c768-3d60-455b-a046-f87dc14868bf | id | |
| spl set id | 9dbc6d1a-8612-41ed-8560-8ba50733e0ea | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a physician. If symptoms do not improve within 7 days or are accompanied by fever, consult a physician. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with possibility of convulsion or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery, and may impair mental alertness in children. Chlorpheniramine has an atropine-like action and should be used with caution in patients with increased intraocular pressure, cardiovascular disease, hypertension or in patients with a history of bronchial asthma. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and sometimes death.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria. Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and, rarely, excitability in children. Symptoms No information is available as to specific results of an overdose of BP Allergy Junior Suspension. However, signs and symptoms may vary from CNS depression to stimulation (restlessness to convulsions). Atropine-like signs and symptoms may be prominent. Overdosage in young children may lead to convulsions and death in severe cases. Treatment Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.