FDA.reportPublic FDA data

Rugby Travel Sickness

Manufacturer
Apotheca Inc.
Effective date
2015-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:28

Label at a glance#

ProductRugby Travel Sickness Meclizine HCl, 25 mg Each (ANTIEMETIC)
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 older: Chew 1-2 tablets 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

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl USP 25 mg


Purpose

OTC - PURPOSE SECTION

Antiemetic


Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION


OTC - DO NOT USE SECTION

Do not use in 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.


When using this product

OTC - WHEN USING SECTION

  • 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.


Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact the poison control center immediately.


Directions

DOSAGE & ADMINISTRATION SECTION

Dosage should be taken one hour before travel starts

Adults and children 12 years of age and older:

Chew 1-2 tablets 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


Other information

SPL UNCLASSIFIED SECTION


  • Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.


Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158


OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN1
995632meclizine hydrochloride 25 MG Chewable TabletSCD1

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-246-002020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-012020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-712020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-792020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-802020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-852020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-912020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts
12634-246-962020-01-31C16284748780-19d75b9d0-d870-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-246-00Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)10 in 1 BOTTLETABLET, CHEWABLE101
12634-246-01Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)100 in 1 BOTTLETABLET, CHEWABLE1001
12634-246-71Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)30 in 1 BOTTLETABLET, CHEWABLE301
12634-246-79Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)25 in 1 BOTTLETABLET, CHEWABLE251
12634-246-80Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)20 in 1 BOTTLETABLET, CHEWABLE201
12634-246-85Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)15 in 1 BOTTLETABLET, CHEWABLE151
12634-246-91Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)1 in 1 BLISTER PACKTABLET, CHEWABLE11
12634-246-96Rugby Travel SicknessMeclizine HCl, 25 mg Each (ANTIEMETIC)6 in 1 BOTTLETABLET, CHEWABLE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-246RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE [APOTHECA INC.]1Legacy NDC, 8 package rows20151229_280dc4d4-7773-3c13-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1018-01EA - Each0536-101838974734-0ca3-472f-a497-87a548eaec9412014-09-03
0536-1018-10EA - Each0536-1018f375fa7f-4c57-4dd0-8d08-870621e0e1e712014-10-03

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12634-24612634-246-00, 12634-246-01, 12634-246-71, 12634-246-79, 12634-246-80, 12634-246-85, 12634-246-91, 12634-246-96
0536-1018

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM SULFATE0YPR65R21JIACT
SUCROSEC151H8M554IACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

Source Document#

Source XML · Source PDF

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
280dc4d4-7774-3c13-e054-00144ff8d46c280dc4d4-7773-3c13-e054-00144ff8d46c2015-12-29WarningsExact identifier
spl id: 280dc4d4-7774-3c13-e054-00144ff8d46c
spl set id: 280dc4d4-7773-3c13-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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