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
- Direct_Rx
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- e79ecf77-0e0a-d7ef-e053-2a95a90a5adf
- SPL ID
- 15ac00f8-da4e-6cea-e063-6294a90aeb81
- Version
- 4
- Effective date
- 2024-04-09
- 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 06:35:28
| 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 | NDA | 010721 | derived:openfda.application_number |
| application number | NDA010721 | openfda.application_number | |
| brand name | Meclizine Hydrochloride | openfda.brand_name | |
| generic name | MECLIZINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Direct_Rx | openfda.manufacturer_name | |
| ndc | package | 72189-237-90 | openfda.package_ndc |
| ndc | package | 72189-237-30 | openfda.package_ndc |
| ndc | product | 72189-237 | openfda.product_ndc |
| ndc11 | package | 72189023790 | derived:openfda.package_ndc |
| ndc11 | package | 72189023730 | derived:openfda.package_ndc |
| rxcui | 995666 | openfda.rxcui | |
| spl id | 15ac00f8-da4e-6cea-e063-6294a90aeb81 | id | |
| spl set id | e79ecf77-0e0a-d7ef-e053-2a95a90a5adf | set_id | |
| unii | HDP7W44CIO | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5.1 Drowsiness Since drowsiness may occur with use of meclizine hydrochloride, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking meclizine hydrochloride [see DRUG INTERACTIONS (7.1)]. 5.2 Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.