FDA.reportPublic FDA data

BONINE

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2025-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:00

Label at a glance#

ProductBONINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Dosage and administration

dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor

Storage and handling

store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F) see end flap for expiration date and lot number protect from heat and humidity

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

Do not use 

OTC - DO NOT USE SECTION

in children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • drowsiness may occur
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dosage should be taken one hour before travel starts
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number
  • protect from heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, saccharin sodium, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1 (844) 241-5454 or www.bonine.com 

Dist. by:

SPL UNCLASSIFIED SECTION

WellSpring Pharmaceutical
Corporation Sarasota, FL 34243
©2025 WellSpring Pharmaceutical Corporation

TAMPER EVIDENT: DO NOT USE IF PRINTED TEAR STRIP IS BROKEN OR MISSING

MONEY BACK GUARANTEE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-297

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRAVEL SIZE

Less drowsy vs. Dramamine® dimenhydrinate. Dramamine® is a registered trademark of Medtech Products Inc.

9X the Adventure** Meclizine HCl • Antiemetic 25 mg

bonine 12ct
bonine 12ct
bonine 12 ct
bonine 12 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995634Bonine 25 MG Chewable TabletPSN2
995632meclizine HCl 25 MG Chewable TabletPSN2
995634meclizine hydrochloride 25 MG Chewable Tablet [Bonine]SBD2
995632meclizine hydrochloride 25 MG Chewable TabletSCD2
995634Bonine 25 MG Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130365197275120GTIN-13: 0365197275120
EAN-13: 0365197275120
GTIN-12: 365197275120
UPC-A: 365197275120
GTIN storage (14 digits): 00365197275120		bonine-chewable-tablets-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65197-297-08BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
65197-297-08BONINE1 in 1 BOXTABLET, CHEWABLE12
65197-297-12BONINE12 in 1 BOTTLETABLET, CHEWABLE122
65197-297-12BONINE1 in 1 BOXTABLET, CHEWABLE12
65197-297-16BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
65197-297-16BONINE2 in 1 BOXTABLET, CHEWABLE22
65197-297-24BONINE3 in 1 CARTONTABLET, CHEWABLE32
65197-297-24BONINE8 in 1 BLISTER PACKTABLET, CHEWABLE82
65197-297-48BONINE3 in 1 CARTONTABLET, CHEWABLE32
65197-297-48BONINE2 in 1 CARTONTABLET, CHEWABLE22

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-29765197-297-08, 65197-297-12, 65197-297-16, 65197-297-24, 65197-297-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
FD&C RED NO. 40WZB9127XOAIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BONINEMECLIZINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation0b2ea6b8-b342-4940-8922-898758fbeb312025-03-21WarningsExact identifier
ndc (package): 65197-297-48
ndc (package): 65197-297-12
ndc (package): 65197-297-08
ndc (package): 65197-297-24
ndc (package): 65197-297-16
ndc (product): 65197-297
ndc11 (package): 65197029748
ndc11 (package): 65197029708
ndc11 (package): 65197029724
ndc11 (package): 65197029716
ndc11 (package): 65197029712
spl id: 9e33d2ae-5059-4214-b50f-fa5731f6f9ed
spl set id: 0b2ea6b8-b342-4940-8922-898758fbeb31

Reported adverse events (FAERS/openFDA)#

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