Carbinoxamine Maleate
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
- Brand name
- Carbinoxamine Maleate
- Generic name
- CARBINOXAMINE MALEATE
- Manufacturer
- TRIPOINT THERAPEUTICS, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 91ee2e99-082a-4157-b71b-1a7c0e5464fa
- SPL ID
- 28237aea-8a3c-40ca-b2a1-0b7248ce5b99
- Version
- 2
- Effective date
- 2025-08-05
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:16:32
| Harmonized routes |
|---|
| ORAL |
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 |
|---|---|---|---|
| application applno | ANDA | 215476 | derived:openfda.application_number |
| application number | ANDA215476 | openfda.application_number | |
| brand name | Carbinoxamine Maleate | openfda.brand_name | |
| generic name | CARBINOXAMINE MALEATE | openfda.generic_name | |
| manufacturer name | TRIPOINT THERAPEUTICS, LLC | openfda.manufacturer_name | |
| ndc | package | 80705-120-30 | openfda.package_ndc |
| ndc | product | 80705-120 | openfda.product_ndc |
| ndc11 | package | 80705012030 | derived:openfda.package_ndc |
| rxcui | 1795581 | openfda.rxcui | |
| spl id | 28237aea-8a3c-40ca-b2a1-0b7248ce5b99 | id | |
| spl set id | 91ee2e99-082a-4157-b71b-1a7c0e5464fa | set_id | |
| unii | 02O55696WH | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Deaths have been reported in children less than 2 years of age who were taking antihistamines, including carbinoxamine-containing drug products, therefore, carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS ). Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.
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: Body as a whole: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis Central nervous system: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation Urogenital: Urinary frequency, difficult urination, urinary retention, early menses Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Tripoint Therapeutics at AE_PC@tripointtherapeutics.com.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.