FDA.reportPublic FDA data

MECLIZINE

Manufacturer
Advanced Rx LLC | Pharbest Pharmaceuticals, Inc.
Effective date
2025-09-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:13:09

Label at a glance#

ProductMECLIZINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

dosage should be taken 1 hour before travel starts  adults and children 12 years and over take 2 or 4 caplets once daily or as directed by a doctor

Storage and handling

Tamper Evident: do not use if safety seal under cap is broken or missing each caplet contains: calcium 28 mg store at room temperature 20°-25°C (68°-77°F).

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 12.5mg

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 usein children under 12 years of age unless directed by a doctor.

Do not take unless directed by a doctor if you have

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

Do not take if you aretaking 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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • dosage should be taken 1 hour before travel starts 
adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • each caplet contains: calcium 28 mg
  • store at room temperature 20°-25°C (68°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-630-8895, 8:30 am - 4:30 pm ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN1
995624meclizine hydrochloride 12.5 MG Oral 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
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-427-02MECLIZINE200 in 1 BOTTLE, PLASTICTABLET2001

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80513-42780513-427-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

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
MECLIZINEMECLIZINE HCL 12.5 MGAdvanced Rx LLC032a89f2-17e7-45d2-94a1-cc7a601ebdee2025-09-01WarningsExact identifier
ndc (package): 80513-427-02
ndc (product): 80513-427
ndc11 (package): 80513042702
spl id: 3e5a4128-ff9c-6f2b-e063-6394a90a42e6
spl set id: 032a89f2-17e7-45d2-94a1-cc7a601ebdee

Reported adverse events (FAERS/openFDA)#

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