FDA.reportPublic FDA data

Meclizine HCL 12.5 mg

Manufacturer
Advance Pharmaceutical Inc.
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:51

Label at a glance#

ProductMeclizine HCL 12.5 mg
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

prevents and treats nausea, vomiting, or dizziness due to motion sickness for other uses, consult your doctor

Dosage and administration

adults & children 12 years and over: 2-4 caplets once daily children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active indredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCL 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

  • prevents and treats nausea, vomiting, or dizziness due to motion sickness
  • for other uses, consult your doctor

Warnings

WARNINGS SECTION

Ask a docotor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble 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

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquillizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranqulizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

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

  • adults & children 12 years and over: 2-4 caplets once daily
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 51 mg
  • store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 17714-117-01

Meclizine 12.5mg caplets

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN2
995624meclizine hydrochloride 12.5 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
17714-117-01Meclizine HCL 12.5 mg100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-117MECLIZINE HCL 12.5 MG TABLET [ADVANCE PHARMACEUTICAL INC.]2Current NDC, Legacy NDC, 1 package rows20171031_76efad7e-e765-430f-9232-63553d02f2c5.zip

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
17714-11717714-117-01

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
STEARIC ACID4ELV7Z65APIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
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
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGAdvance Pharmaceutical Inc.76efad7e-e765-430f-9232-63553d02f2c52017-10-30WarningsExact identifier
ndc (package): 17714-117-01
ndc (product): 17714-117
ndc11 (package): 17714011701
spl id: 5cc9755e-6d41-fa9f-e053-2991aa0afbef
spl set id: 76efad7e-e765-430f-9232-63553d02f2c5

Reported adverse events (FAERS/openFDA)#

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