FDA.reportPublic FDA data

Rugby

Manufacturer
RedPharm Drug, Inc. | RedPharm Drug Inc.
Effective date
2014-03-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:52

Label at a glance#

ProductRugby
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

Other information Each Caplet Contains: Calcium 25 mg store at room temperature in a dry place Keep lid tightly closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Meclizine HCl, USP 12.5 mg

PURPOSE

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS

WARNINGS SECTION

Warnings

Do not use in children under 12 years of age unless directed by a doctor

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 product

​may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution 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 the poison control center immediately.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

Dosage should be taken one hour before travel starts.
Adults and children 12 years of age and older: take 2-4 caplets once daily, or as directed by a doctor
Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

Other information

Each Caplet Contains: Calcium 25 mg
store at room temperature in a dry place
Keep lid tightly closed

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients

croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

QUESTIONS

OTC - QUESTIONS SECTION

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

OTC KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meclizine 12.5mgmeclizine 12.5mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN2
995624meclizine hydrochloride 12.5 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1252-32020-01-31C16284748780-19d75b9d0-d9db-f424-e053-dadaa90a57ce4fa706cc-56e7-1ed0-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1252-3Rugby30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1252RUGBY TABLET [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20170516_4fa706cc-56e7-1ed0-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1017-01EA - Each0536-1017d858cbd4-182d-4c28-9d84-1eaca79de4b312014-11-05
0536-1017-10EA - Each0536-1017f3492dff-8835-4cfb-bc54-f996b4e4162712014-11-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67296-125267296-1252-3
0536-1017

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
SODIUM SULFATE0YPR65R21JIACT

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
4fa706cc-56e8-1ed0-e054-00144ff8d46c4fa706cc-56e7-1ed0-e054-00144ff8d46c2014-03-07WarningsExact identifier
spl id: 4fa706cc-56e8-1ed0-e054-00144ff8d46c
spl set id: 4fa706cc-56e7-1ed0-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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