BONINE

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: BONINE
Generic name: MECLIZINE HYDROCHLORIDE
Manufacturer: WellSpring Pharmaceutical Corporation
Product type: HUMAN OTC DRUG
SPL set ID: ad3d66ca-a52c-43ba-b9e2-6269b8a413a9
SPL ID: 7c66f984-240b-40dc-affd-9f1562f57c7c
Version: 20
Effective date: 2025-03-21
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:56:48

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 · 29 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M009	openfda.application_number
brand name		BONINE	openfda.brand_name
generic name		MECLIZINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		WellSpring Pharmaceutical Corporation	openfda.manufacturer_name
ndc	package	65197-296-24	openfda.package_ndc
ndc	package	65197-296-32	openfda.package_ndc
ndc	package	65197-296-12	openfda.package_ndc
ndc	package	65197-296-08	openfda.package_ndc
ndc	package	65197-296-16	openfda.package_ndc
ndc	package	65197-275-12	openfda.package_ndc
ndc	package	65197-275-08	openfda.package_ndc
ndc	package	65197-275-16	openfda.package_ndc
ndc	package	65197-275-02	openfda.package_ndc
ndc	product	65197-275	openfda.product_ndc
ndc	product	65197-296	openfda.product_ndc
ndc11	package	65197029632	derived:openfda.package_ndc
ndc11	package	65197027512	derived:openfda.package_ndc
ndc11	package	65197027508	derived:openfda.package_ndc
ndc11	package	65197027516	derived:openfda.package_ndc
ndc11	package	65197029624	derived:openfda.package_ndc
ndc11	package	65197029612	derived:openfda.package_ndc
ndc11	package	65197027502	derived:openfda.package_ndc
ndc11	package	65197029608	derived:openfda.package_ndc
ndc11	package	65197029616	derived:openfda.package_ndc
rxcui		995634	openfda.rxcui
rxcui		995632	openfda.rxcui
spl id		7c66f984-240b-40dc-affd-9f1562f57c7c	id
spl set id		ad3d66ca-a52c-43ba-b9e2-6269b8a413a9	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 trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis 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 you may get drowsy 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.

Reported adverse events (FAERS/openFDA)#

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