Medique Medi-Meclizine

Manufacturer
A-S Medication Solutions
Effective date
2021-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:39:45

Label at a glance#

ProductMedique Medi-Meclizine
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Dosage and administration

do not use more than directed to prevent motion sickness, take the first dose one hour before starting activity Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine Hydrochloride 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

if you are

SPL UNCLASSIFIED SECTION

  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • to prevent motion sickness, take the first dose one hour before starting activity

SPL UNCLASSIFIED SECTION

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

SPL UNCLASSIFIED SECTION

Children under 12 years: Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 59- 86º F (15-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow # 10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-634-7680

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4493

NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

MECLIZINE HYDROCHLORIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995666meclizine HCl 25 MG Oral TabletPSN3
995666meclizine hydrochloride 25 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4493-02023-01-30C16284748780-1f386c649-c361-0266-e053-dadaa90a7c1ad7419e82-55d7-4699-a2d5-c45c54f845c7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4493-0Medique Medi-Meclizine500 in 1 BOXTABLET5003
50090-4493-0Medique Medi-Meclizine2 in 1 PACKETTABLET23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4493MEDIQUE MEDI-MECLIZINE (MECLIZINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210417_d7419e82-55d7-4699-a2d5-c45c54f845c7.zip

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
50090-449350090-4493-0
47682-480

Ingredients#

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

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

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
81f218cb-345b-4f3f-8aff-bdc40d0bc9a3d7419e82-55d7-4699-a2d5-c45c54f845c72021-04-15WarningsExact identifier
spl id: 81f218cb-345b-4f3f-8aff-bdc40d0bc9a3
spl set id: d7419e82-55d7-4699-a2d5-c45c54f845c7

Reported adverse events (FAERS/openFDA)#

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