MECLIZINE

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 (canonical bytes are SHA-256 checked before publication)

Brand name: MECLIZINE
Generic name: MECLIZINE HCL 12.5 MG
Manufacturer: Advanced Rx LLC
Product type: HUMAN OTC DRUG
SPL set ID: 032a89f2-17e7-45d2-94a1-cc7a601ebdee
SPL ID: 3e5a4128-ff9c-6f2b-e063-6394a90a42e6
Version: 1
Effective date: 2025-09-01
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:26:07

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M009	openfda.application_number
brand name		MECLIZINE	openfda.brand_name
generic name		MECLIZINE HCL 12.5 MG	openfda.generic_name
manufacturer name		Advanced Rx LLC	openfda.manufacturer_name
ndc	package	80513-427-02	openfda.package_ndc
ndc	product	80513-427	openfda.product_ndc
ndc11	package	80513042702	derived:openfda.package_ndc
rxcui		995624	openfda.rxcui
spl id		3e5a4128-ff9c-6f2b-e063-6394a90a42e6	id
spl set id		032a89f2-17e7-45d2-94a1-cc7a601ebdee	set_id
unii		HDP7W44CIO	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not use in children under 12 years of age unless directed by a doctor. Do not take unless directed by a doctor if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.