boxed warning
TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING
Meclizine Hydrochloride
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
- Meclizine Hydrochloride
- Generic name
- MECLIZINE HYDROCHLORIDE
- Manufacturer
- APNAR PHARMA LP
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e4d785a7-a688-3acb-e053-2a95a90a6d2e
- SPL ID
- 2b4a16c2-d9c9-61ab-e063-6394a90a863a
- Version
- 2
- Effective date
- 2025-01-09
- Source export date
- 2026-11-06
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/d46c999c1947092f6e18e5233482e6d1c02312c89d32ce906e3b19672a696546/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
- Import run
- 20261106T075659Z
- Imported at
- 2026-11-06 08:07:57
| 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 number | M009 | openfda.application_number | |
| brand name | Meclizine Hydrochloride | openfda.brand_name | |
| generic name | MECLIZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | APNAR PHARMA LP | openfda.manufacturer_name | |
| ndc | package | 24689-138-01 | openfda.package_ndc |
| ndc | package | 24689-139-01 | openfda.package_ndc |
| ndc | product | 24689-139 | openfda.product_ndc |
| ndc | product | 24689-138 | openfda.product_ndc |
| ndc11 | package | 24689013801 | derived:openfda.package_ndc |
| ndc11 | package | 24689013901 | derived:openfda.package_ndc |
| rxcui | 995624 | openfda.rxcui | |
| rxcui | 995666 | openfda.rxcui | |
| spl id | 2b4a16c2-d9c9-61ab-e063-6394a90a863a | id | |
| spl set id | e4d785a7-a688-3acb-e053-2a95a90a6d2e | set_id | |
| unii | HDP7W44CIO | openfda.unii |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Do not use in children under 12 years of age unless directed by a doctor Do not take this product, unless directed by a doctor, if you have Glaucoma A breathing problem such as emphysema or chronic bronchitis Trouble urination due to an enlarged prostate gland Do not take this product if you are taking Sedatives or tranquilizers, without first consulting your doctor. When using this product, Do not exceed recommended dosage may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.