FDA label 6158ab24-cb5c-45d8-9494-a7080e9e80b1
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
- ff934673-8bd4-4119-8e30-dced2873413b
- SPL ID
- 6158ab24-cb5c-45d8-9494-a7080e9e80b1
- Version
- 1
- Effective date
- 2010-10-28
- 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 02:50:33
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 | 6158ab24-cb5c-45d8-9494-a7080e9e80b1 | id | |
| spl set id | ff934673-8bd4-4119-8e30-dced2873413b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Hypertensive crisis can occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy), indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued, and therapy to lower blood pressure should be instituted immediately. Fever should be managed by external cooling. Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients. Do no exceed recommended dosage. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.
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 to Mintuss™ DR Syrup include sedation, dryness of mouth, nose and throat, thickening of bronchial secretions, and dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity,and pruritus. Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias. Central Nervous System: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria. Gastrointestinal System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea or constipation. Genitourinary System: Urinary frequency, difficult urination. 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.