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 25MG
Manufacturer: Pharbest Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 4bac2765-045c-405e-8006-8c5cfdfa89bc
SPL ID: f25eaba1-2538-4b14-bc67-aa45e07b3014
Version: 4
Effective date: 2025-12-24
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:46:03

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 · 13 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 25MG	openfda.generic_name
manufacturer name		Pharbest Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	16103-387-08	openfda.package_ndc
ndc	package	16103-387-11	openfda.package_ndc
ndc	product	16103-387	openfda.product_ndc
ndc11	package	16103038711	derived:openfda.package_ndc
ndc11	package	16103038708	derived:openfda.package_ndc
rxcui		995632	openfda.rxcui
spl id		f25eaba1-2538-4b14-bc67-aa45e07b3014	id
spl set id		4bac2765-045c-405e-8006-8c5cfdfa89bc	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 this product 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800-222-1222)

Reported adverse events (FAERS/openFDA)#

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