RYCLORA
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
- RYCLORA
- Generic name
- DEXCHLORPHENIRAMINE MALEATE
- Manufacturer
- CARWIN PHARMACEUTICAL ASSOCIATES, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- aa4f80c9-e600-4bc0-8528-02a8162a36f0
- SPL ID
- 3affdd03-252d-443c-9966-e3aec314fb98
- Version
- 2
- Effective date
- 2024-01-08
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:53:14
| 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 | 202520 | derived:openfda.application_number |
| application number | ANDA202520 | openfda.application_number | |
| brand name | RYCLORA | openfda.brand_name | |
| generic name | DEXCHLORPHENIRAMINE MALEATE | openfda.generic_name | |
| manufacturer name | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | openfda.manufacturer_name | |
| ndc | package | 15370-150-16 | openfda.package_ndc |
| ndc | package | 15370-150-04 | openfda.package_ndc |
| ndc | package | 15370-150-99 | openfda.package_ndc |
| ndc | product | 15370-150 | openfda.product_ndc |
| ndc11 | package | 15370015004 | derived:openfda.package_ndc |
| ndc11 | package | 15370015016 | derived:openfda.package_ndc |
| ndc11 | package | 15370015099 | derived:openfda.package_ndc |
| rxcui | 2183907 | openfda.rxcui | |
| rxcui | 2183912 | openfda.rxcui | |
| spl id | 3affdd03-252d-443c-9966-e3aec314fb98 | id | |
| spl set id | aa4f80c9-e600-4bc0-8528-02a8162a36f0 | set_id | |
| unii | B10YD955QW | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Antihistamines should be used with considerable caution in patients with: Narrow angle glaucoma Stenosing peptic ulcer Pyloroduodenal obstruction Symptomatic prostatic hypertrophy Bladder neck obstruction Use in Children In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation. Use in Pregnancy Experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus. Use with CNS Depressants RYCLORA™ Oral Solution has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.). Use in Activities Requiring Mental Alertness Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. Use in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and the throat. Cardiovascular System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. 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, neuritis, convulsions. 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. Call your doctor for medical advice about side effects. You may voluntarily report side effects to FDA at 1-800-FDA-1088. Questions or comments? Call Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.