FDA.reportPublic FDA data

Meclizine HCL 25 mg

Manufacturer
Proficient Rx LP
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:41:34

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

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-606-30

Meclizine HCL 25 mg

ANTIEMETIC

30 TABLETS

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

*Compare to Active Ingredient in BONINE®

71205-606-30
71205-606-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN4
995632meclizine hydrochloride 25 MG Chewable TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371205606305GTIN-13: 0371205606305
EAN-13: 0371205606305
GTIN-12: 371205606305
UPC-A: 371205606305
GTIN storage (14 digits): 00371205606305		image-01.jpg
Data codeData Matrix010037120560630521MASTER<GS>171000000image-01.jpg
Data codeData MatrixQM060630*71205-606-30*#30*00000*69618-0028-01*000000*MASTERimage-01.jpg

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
71205-606-30Meclizine HCL 25 mg30 in 1 BOTTLE, PLASTICTABLET304
71205-606-60Meclizine HCL 25 mg60 in 1 BOTTLE, PLASTICTABLET604
71205-606-90Meclizine HCL 25 mg90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-606-30EA - Each71205-60689874bdc-fef7-4df4-8aa2-57fac60f86dc12022-03-09
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
71205-60671205-606-30, 71205-606-60, 71205-606-90
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
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
RASPBERRY4N14V5R27WIACT
ASPARTAMEZ0H242BBR1IACT
SUCROSEC151H8M554IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-01-01full-release2026-06-01 00:07:52

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 HCLProficient Rx LPd08fa6f5-4293-4468-814e-7dccbd2812092025-10-01WarningsExact identifier
ndc (package): 71205-606-30
ndc (package): 71205-606-90
ndc (package): 71205-606-60
ndc (product): 71205-606
ndc11 (package): 71205060630
ndc11 (package): 71205060690
ndc11 (package): 71205060660
spl id: f7855d32-3393-4704-a412-b978bf4962cf
spl set id: d08fa6f5-4293-4468-814e-7dccbd281209
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
ndc (product): 69618-028

Reported adverse events (FAERS/openFDA)#

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