Meclizine HCL 25 mg

Manufacturer
REMEDYREPACK INC.
Effective date
2021-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:37:16

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®.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Meclizine HCL 25 mg

GENERIC: Meclizine HCL

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-3201-0

COLOR: pink

FLAVOR: RASPBERRY

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: AP;115

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • MECLIZINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

  • DEXTROSE
  • FD&C RED NO. 40
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • RASPBERRY
  • ASPARTAME
  • SUCROSE
  • CROSCARMELLOSE SODIUM

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3201-02025-09-11C16284748780-1f386c649-dbf3-0266-e053-dadaa90a7c1aMeclizine HCL 25 mg
70518-3201-02023-01-30C16284748780-1f386c649-dbf3-0266-e053-dadaa90a7c1aMeclizine HCL 25 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3201MECLIZINE HCL 25 MG (MECLIZINE HCL) TABLET [REMEDYREPACK INC.]1Legacy NDC20210829_839e4645-dabf-473b-80f7-850d4b2bdc8b.zip

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
70518-320170518-3201-0
69618-028

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 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
138fd3f9-5eba-f3d3-e063-6294a90a2152839e4645-dabf-473b-80f7-850d4b2bdc8b2024-03-13WarningsExact identifier
spl set id: 839e4645-dabf-473b-80f7-850d4b2bdc8b

Reported adverse events (FAERS/openFDA)#

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