FDA label 2d2db7bb-8a58-4bb5-a083-29a739fba5e6
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
- 5f5322ce-09ad-4958-81de-96ffc94933a5
- SPL ID
- 2d2db7bb-8a58-4bb5-a083-29a739fba5e6
- Version
- 2
- Effective date
- 2017-02-16
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:31:30
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 | 2d2db7bb-8a58-4bb5-a083-29a739fba5e6 | id | |
| spl set id | 5f5322ce-09ad-4958-81de-96ffc94933a5 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Do not exceed the recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. If a hypertensive crisis occurs, these drugs should be discontiued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.
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 Zotex™-C Syrup include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: General: urinary, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat. Cardiovascular System: hypotension, headache, palpitations, tachycardia, extra systoles. Dermatologic: urticaria, drug rash, photosensitivity, and pruritus. Central Nervous System: sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, peuritus convulsions. Gastrointestinal: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary: urinary frequency, difficult urination, urinary retention, early mensea. Respiratory: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Hematologic System: hemolytic anemia, thrombocytopenia, agranulocytosis.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.