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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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

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.