FDA.reportPublic FDA data

Meclizine HCL 25 mg

Manufacturer
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Effective date
2021-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:54:16

Label at a glance#

ProductMeclizine HCL 25 mg
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

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

Dosage and administration

take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: 1-2 tablets once daily children unser 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCL 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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

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

When using this prodcut

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers 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 - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers 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

  • take dose one hour before travel starts
  • tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70934-197-30

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-197-302021-01-31C16284748780-1ba0f9c33-4362-a910-e053-dadaa90a0b85Meclizine HCL 25 mg
70934-197-302021-01-29C16284748780-1ba0f9c33-4362-a910-e053-dadaa90a0b85Meclizine HCL 25 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-028-01EA - Each69618-02805854f16-ef26-4281-a82d-55afaf652f5212016-05-16
69618-028-10EA - Each69618-02834099ed8-cfa9-415b-92f0-ce00963c6a3612016-05-16

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70934-19770934-197-30
69618-028

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
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
RASPBERRY4N14V5R27WIACT
ASPARTAMEZ0H242BBR1IACT
SUCROSEC151H8M554IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
DEXTROSEIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
ndc (product): 69618-028
c8266f5e-0140-94f8-e053-2995a90ac56086ac7223-b836-bc0c-e053-2991aa0a32f22021-07-27WarningsExact identifier
spl set id: 86ac7223-b836-bc0c-e053-2991aa0a32f2

Reported adverse events (FAERS/openFDA)#

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