FDA.reportPublic FDA data

Meclizine Hydrochloride Tablets

Manufacturer
APNAR PHARMA LP | INVAHEALTH INC | APNAR PHARMA LLP
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:22

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 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

12.5mg tablet: Meclizine HCL.... 12.5 mg

25mg tablet : Meclizine HCL .....25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE SECTION

Uses

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

DOSAGE & ADMINISTRATION SECTION

Directions

Meclizine HCL 12.5mg tablet :

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor

Meclizine HCL 25mg tablet:

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

STORAGE AND HANDLING SECTION

Other Information:

store at 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]

WARNINGS SECTION

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

Do not take this product, unless directed by a doctor, if you have

  • Glaucoma
  • A breathing problem such as emphysema or chronic bronchitis
  • Trouble urination due to an enlarged prostate gland

Do not take this product if you are taking

Sedatives or tranquilizers, without first consulting your doctor.

When using this product,

  • Do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 (1-800-222-1222)

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 05/2022

Made in USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

BOXED WARNING SECTION

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC : 24689-138-01

Meclizine Hydrochloride Tablets 12.5 mg

Antiemetic

100 Tablets

Meclizine HCl 12.5 mg tablets -100sMeclizine HCl 12.5 mg tablets -100s

NDC : 24689-139-01

Meclizine Hydrochloride Tablets 25 mg

Antiemetic

100 Tablets

Meclizine HCl 25 mg _label-100sMeclizine HCl 25 mg _label-100s

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN2
995666meclizine HCl 25 MG Oral TabletPSN2
995624meclizine hydrochloride 12.5 MG Oral TabletSCD2
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
24689-138-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1002
24689-139-01Meclizine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-138MECLIZINE HYDROCHLORIDE TABLET [APNAR PHARMA LP]2Current NDC, Legacy NDC, 1 package rows20250112_e4d785a7-a688-3acb-e053-2a95a90a6d2e.zip
24689-139MECLIZINE HYDROCHLORIDE TABLET [APNAR PHARMA LP]2Current NDC, Legacy NDC, 1 package rows20250112_e4d785a7-a688-3acb-e053-2a95a90a6d2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-138-01EA - Each24689-138574573b9-a5c0-4464-83ef-c2c265984a0812022-09-12
24689-139-01EA - Each24689-13943d80244-7dd5-4c13-a8d3-6d059240f2ad12022-09-12

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24689-13824689-138-01
24689-13924689-139-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT

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 LPe4d785a7-a688-3acb-e053-2a95a90a6d2e2025-01-09Boxed warning, WarningsExact identifier
ndc (package): 24689-138-01
ndc (package): 24689-139-01
ndc (product): 24689-139
ndc (product): 24689-138
ndc11 (package): 24689013801
ndc11 (package): 24689013901
spl id: 2b4a16c2-d9c9-61ab-e063-6394a90a863a
spl set id: e4d785a7-a688-3acb-e053-2a95a90a6d2e

Reported adverse events (FAERS/openFDA)#

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