FDA.reportPublic FDA data

Rugby Meclizine HCl

Manufacturer
RUGBY LABORATORIES
Effective date
2020-11-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:07:27

Label at a glance#

ProductRugby Meclizine HCl
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure12 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

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Meclizine HCl, USP 12.5 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

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.

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

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 SECTION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or comments?

Call1-800-645-2158

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1178-01

NEW FORMULA AND APPEARANCE

Meclizine HCl, USP

12.5 mg Each

ANTIEMETIC

100 CAPLETS

0536-1178 100-ct0536-1178 100-ct

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1178-01EA - Each0536-11782ee7f91a-678f-4a87-9885-44db3c91f57712018-06-11
0536-1178-10EA - Each0536-1178d4328bc0-e7f7-4489-b8f0-16f7feb34b5212018-06-11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11780536-1178-01, 0536-1178-10

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
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM SULFATE0YPR65R21JIACT
STEARIC ACID4ELV7Z65APIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT

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
b3db13b7-cd9f-1e60-e053-2995a90acb366a48ec0c-773d-7f97-e053-2991aa0a03512020-11-11WarningsExact identifier
spl id: b3db13b7-cd9f-1e60-e053-2995a90acb36
spl set id: 6a48ec0c-773d-7f97-e053-2991aa0a0351

Reported adverse events (FAERS/openFDA)#

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