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
- ed43bf21-f3da-245c-e053-2995a90a504c
- SPL ID
- 2b4a3632-89d2-8d7d-e063-6294a90a71e1
- Version
- 2
- Effective date
- 2025-01-09
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:18:15
| 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 | 24689-146-01 | openfda.package_ndc |
| ndc | product | 24689-146 | openfda.product_ndc |
| ndc11 | package | 24689014601 | derived:openfda.package_ndc |
| rxcui | 995666 | openfda.rxcui | |
| spl id | 2b4a3632-89d2-8d7d-e063-6294a90a71e1 | id | |
| spl set id | ed43bf21-f3da-245c-e053-2995a90a504c | 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
Warnings Do not use in children under 12 years of age unless directed by a doctor. Ask a doctor before use if you have • glaucoma • breathing problems, such as emphysema or chronic bronchitis • difficulty urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase drowsiness • 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.