Meclizine Hydrochloride Tablets 25 mg

Manufacturer
APNAR PHARMA LP | APNAR PHARMA LLP
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:23

Label at a glance#

ProductMeclizine Hydrochloride
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure12 sections

Boxed warning

Tamper evident:Do not use if safety seal is broken or missing

Storage and handling

Other information store at room temperature 15˚-30˚C (59˚-86˚F) protect from humidity

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Meclizine HCL 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE SECTION

Uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

WARNINGS SECTION

Warnings

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

Ask a doctor before use if you have

• glaucoma

• breathing problems, such as emphysema or chronic bronchitis

• difficulty urinating due to an enlarged prostate gland

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

When using this product

• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery


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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • to prevent motion sickness, take the first dose one hour before starting activity
  • not for frequent or prolonged use except on the advice of a doctor
  • do not exceed recommended dose

Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 15˚-30˚C (59˚-86˚F)
  • protect from humidity

INACTIVE INGREDIENT SECTION

Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-855-642-2594

BOXED WARNING SECTION

Tamper evident:Do not use if safety seal is broken or missing

SPL UNCLASSIFIED SECTION

Comapre to active ingredient in DRAMAMINE ® ALL DAY LESS DROWSY*

*This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ®

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Rev.:10/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24689-146-01

Meclizine HCL 25 mg

Antiemetic

100 Tablets

Meclizine HCl 25 mg YELLOW _labelMeclizine HCl 25 mg YELLOW _label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995666meclizine HCl 25 MG Oral TabletPSN2
995666meclizine hydrochloride 25 MG Oral TabletSCD2

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
24689-146-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-146MECLIZINE HYDROCHLORIDE TABLET [APNAR PHARMA LP]2Current NDC, Legacy NDC, 1 package rows20250112_ed43bf21-f3da-245c-e053-2995a90a504c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-146-01EA - Each24689-1463e171323-9e53-4ba0-b1a2-09648d23e59812023-02-06

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24689-14624689-146-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPed43bf21-f3da-245c-e053-2995a90a504c2025-01-09Boxed warning, WarningsExact identifier
ndc (package): 24689-146-01
ndc (product): 24689-146
ndc11 (package): 24689014601
spl id: 2b4a3632-89d2-8d7d-e063-6294a90a71e1
spl set id: ed43bf21-f3da-245c-e053-2995a90a504c

Reported adverse events (FAERS/openFDA)#

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