FDA label 85dbd889-e59a-44f4-a7c9-99f0869091f8
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
- a5183ae7-81f9-4771-9609-5544a2712672
- SPL ID
- 85dbd889-e59a-44f4-a7c9-99f0869091f8
- Version
- 2
- Effective date
- 2017-09-15
- Source export date
- 2026-10-12
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:50:04
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 | 85dbd889-e59a-44f4-a7c9-99f0869091f8 | id | |
| spl set id | a5183ae7-81f9-4771-9609-5544a2712672 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Triprolidine and pseudoephedrine hydrochlorides and codeine phosphate syrup should be used with considerable caution in patients with increased intraocular pressure (narrow angle glaucoma), stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction, hypertension, diabetes mellitus, ischemic heart disease, and hyperthyroidism. In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries. Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS (The most frequent adverse reactions are underlined.) General: Dryness of mouth , dryness of nose , dryness of throat , urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration and chills. Cardiovascular System : Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic System : Hemolytic anemia, thrombocytopenia, agranulocytosis. Nervous System : Sedation , sleepiness , dizziness , disturbed coordination , fatigue, confusion, restlessness, excitation, anxiety, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions, CNS depression, hallucination. G.I. System : Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. G.U. System : Urinary frequency, difficult urination, urinary retention, early menses. Respiratory System : Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness, respiratory depression.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.