BONINE MAX

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 MAX
Generic name: MECLIZINE HYDROCHLORIDE
Manufacturer: WellSpring Pharmaceutical Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 7326a47e-284e-4b6f-8eb0-7933dc1e3f0d
SPL ID: 610a37d5-4aa5-49cf-b50c-0ddda9d1d026
Version: 4
Effective date: 2025-04-11
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:24

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		BONINE MAX	openfda.brand_name
generic name		MECLIZINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		WellSpring Pharmaceutical Corporation	openfda.manufacturer_name
ndc	package	65197-520-17	openfda.package_ndc
ndc	package	65197-520-16	openfda.package_ndc
ndc	product	65197-520	openfda.product_ndc
ndc11	package	65197052017	derived:openfda.package_ndc
ndc11	package	65197052016	derived:openfda.package_ndc
rxcui		2632643	openfda.rxcui
spl id		610a37d5-4aa5-49cf-b50c-0ddda9d1d026	id
spl set id		7326a47e-284e-4b6f-8eb0-7933dc1e3f0d	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 for children under 12 years of age unless directed by a doctor. Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery drowsiness may occur avoid alcoholic drinks 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.