Meclizine HCL 25 mg

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 HCL 25 mg
Generic name: MECLIZINE HCL
Manufacturer: Proficient Rx LP
Product type: HUMAN OTC DRUG
SPL set ID: d08fa6f5-4293-4468-814e-7dccbd281209
SPL ID: f7855d32-3393-4704-a412-b978bf4962cf
Version: 4
Effective date: 2025-10-01
Source export date: 2026-11-06
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:44:51

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M009	openfda.application_number
brand name		Meclizine HCL 25 mg	openfda.brand_name
generic name		MECLIZINE HCL	openfda.generic_name
manufacturer name		Proficient Rx LP	openfda.manufacturer_name
ndc	package	71205-606-30	openfda.package_ndc
ndc	package	71205-606-90	openfda.package_ndc
ndc	package	71205-606-60	openfda.package_ndc
ndc	product	71205-606	openfda.product_ndc
ndc11	package	71205060630	derived:openfda.package_ndc
ndc11	package	71205060690	derived:openfda.package_ndc
ndc11	package	71205060660	derived:openfda.package_ndc
rxcui		995632	openfda.rxcui
spl id		f7855d32-3393-4704-a412-b978bf4962cf	id
spl set id		d08fa6f5-4293-4468-814e-7dccbd281209	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 Ask a doctor before use if you have • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this prodcut • you may get drowsy • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • 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.

Reported adverse events (FAERS/openFDA)#

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