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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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

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.