Label at a glance#

ProductMeclizine Hydrochloride

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Dosage and administration

 Dosage should be taken one hour before travel starts adults and children 12 years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor children under 12 years of age do not give this product to children under 12 years of age unless directed by a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-645-2158

Websitewww.rugbylaboratories.com

www.rugbylaboratories.com

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness due to motion sickness

WARNINGS SECTION

Do not use in

OTC - DO NOT USE SECTION

children under 12 years of age unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

 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

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

 Dosage should be taken one hour before travel starts

adults and children 12 years of age and over	chew 1 to 2 tablets once daily, or as directed by a doctor
children under 12 years of age	do not give this product to children under 12 years of age unless directed by a doctor

Other information

OTHER SAFETY INFORMATION

 Store in a dry place at 15°-30°C (59°-86°F)
 keep lid tightly closed

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
www.rugbylaboratories.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby

NDC 0536-1299-10
Compare to the active ingredient in Bonine®*

Meclizibe 25 mg

Antiemetic

1000 Chewable Tablets

Rugby Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995632	meclizine HCl 25 MG Chewable Tablet	PSN	1
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MECLIZINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1490-3	2025-01-30	C162847	48780-1	2cef2736-6e41-d83d-e063-dadaa90ab31f	5172C- Rubgy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1490-3	Meclizine Hydrochloride	30 in 1 BOTTLE	TABLET, CHEWABLE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1490	MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [REDPHARM DRUG, INC.]	1	1 package rows	20230216_f41ea190-d73d-b8de-e053-2a95a90a076f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1299-10	EA - Each	0536-1299	4be88e27-d239-44c2-93e3-eb1867badd82	1	2021-02-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Meclizine Hydrochloride
CROSPOVIDONE
VANILLA
MAGNESIUM STEARATE
RASPBERRY
STEARIC ACID
SILICON DIOXIDE
FD&C RED NO. 40
LACTOSE MONOHYDRATE
SACCHARIN SODIUM
CROSCARMELLOSE SODIUM
MECLIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67296-1490	67296-1490-3
0536-1299

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CROSPOVIDONE	2S7830E561	IACT
VANILLA	Q74T35078H	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
RASPBERRY	4N14V5R27W	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine Hydrochloride	MECLIZINE HYDROCHLORIDE	Rugby Laboratories	b57f14a7-3852-03db-e053-2a95a90a80d6	2026-07-16	Warnings	Exact identifier ndc (product): 0536-1299
f41ea19e-62e6-297f-e053-2995a90adf91			f41ea190-d73d-b8de-e053-2a95a90a076f	2023-02-07	Warnings	Exact identifier spl id: f41ea19e-62e6-297f-e053-2995a90adf91 spl set id: f41ea190-d73d-b8de-e053-2a95a90a076f

Reported adverse events (FAERS/openFDA)#

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