FDA.reportPublic FDA data

MECLIZINE

Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2021-07-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:39:34

Label at a glance#

ProductMECLIZINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Dosage and administration

doage should be taken 1 hour before travel starts   Adults and children 12 years and over take 1 or 2 tablets once daily or as directed by doctor

Storage and handling

Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

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

Do not take unless directed by a doctor if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • doage should be taken 1 hour before travel starts  
Adults and children 12 years and over

take 1 or 2 tablets once daily or as directed by doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 53002-7651

NDC: 53002-7651-1 10 TABLET, CHEWABLE in a BOTTLE

NDC: 53002-7651-2 20 TABLET, CHEWABLE in a BOTTLE

NDC: 53002-7651-3 30 TABLET, CHEWABLE in a BOTTLE

MECLIZINE (MECLIZINE HCL 25MG) TABLET, CHEWABLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-7651-12023-12-28C16284748780-1f386c64a-0b47-0266-e053-dadaa90a7c1aDrug Facts
53002-7651-22023-12-28C16284748780-1f386c64a-0b47-0266-e053-dadaa90a7c1aDrug Facts
53002-7651-32023-12-28C16284748780-1f386c64a-0b47-0266-e053-dadaa90a7c1aDrug Facts
53002-7651-12023-01-30C16284748780-1f386c64a-0b47-0266-e053-dadaa90a7c1aDrug Facts
53002-7651-22023-01-30C16284748780-1f386c64a-0b47-0266-e053-dadaa90a7c1aDrug Facts
53002-7651-32023-01-30C16284748780-1f386c64a-0b47-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53002-765153002-7651-1, 53002-7651-2, 53002-7651-3
66424-387

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STEARIC ACID4ELV7Z65APIACT

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
b789fa11-c62d-45a1-b657-5b43b6d5525d054dc945-24f9-4369-80d3-e229941de7762023-11-29WarningsExact identifier
spl set id: 054dc945-24f9-4369-80d3-e229941de776

Reported adverse events (FAERS/openFDA)#

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