FDA.reportPublic FDA data

Meclizine Hydrochloride

Manufacturer
CVS Pharmacy, Inc
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:39:23

Label at a glance#

ProductMeclizine Hydrochloride
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for prevention and treatment of these symptoms associated with motion sickness: ■ nausea ■ vomiting ■ dizziness

Dosage and administration

■ To prevent motion sickness, take first dose ½ hour to 1 hour before starting activity ■ To treat motion sickness, take at first signs of symptoms ■ Adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Meclizine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

Uses

INDICATIONS & USAGE SECTION

for prevention and treatment of these symptoms associated with motion sickness:
■ nausea ■ vomiting ■ dizziness

WARNINGS SECTION

Do not give to

OTC - DO NOT USE SECTION

children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

■ drowsiness may occur
■ 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 doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ To prevent motion sickness, take first dose ½ hour to 1 hour before starting activity
■ To treat motion sickness, take at first signs of symptoms
■ Adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

OTHER SAFETY INFORMATION

Store in a dry place at 15° – 30°C (59° – 86°F).

INACTIVE INGREDIENT SECTION

corn starch, colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose

OTC - QUESTIONS SECTION

Questions? 1-800-231-4670

SPL UNCLASSIFIED SECTION

For prevention and treatment of motion sickness

RETAIN VIAL CARD FOR COMPLETE PRODUCT INFORMATION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-34571

*CVS™ is not affiliated with the owner of the registered trademark Dramamine® Less Drowsy.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS™

NDC 69842-857-09

Less Drowsy

MOTION SICKNESS

Meclizine Hydrochloride, Tablets, Antiemetic

Compare to Dramamine® Less Drowsy active ingredient*

Prevents & Relieves: Nausea, Dizziness & Vomiting due to motion sickness

16 TABLETS (25 mg EACH)

TAMPER EVIDENT: USE ONLY IF THIS BLISTER IS INTACT

CVS LabelCVS Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995666meclizine HCl 25 MG Oral TabletPSN4
995666meclizine hydrochloride 25 MG Oral TabletSCD4

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
69842-857-05Meclizine Hydrochloride8 in 1 BLISTER PACKTABLET84
69842-857-05Meclizine Hydrochloride2 in 1 CARTONTABLET24
69842-857-09Meclizine Hydrochloride8 in 1 VIALTABLET84
69842-857-09Meclizine Hydrochloride1 in 1 CARTONTABLET14

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-85769842-857-05, 69842-857-09

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
MAGNESIUM STEARATE70097M6I30IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-02full-release2026-06-01 00:41:03

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 HYDROCHLORIDECVS Pharmacy, Incb57fc6c2-fbfc-24c3-e053-2995a90a33892025-10-16WarningsExact identifier
ndc (package): 69842-857-09
ndc (package): 69842-857-05
ndc (product): 69842-857
ndc11 (package): 69842085705
ndc11 (package): 69842085709
spl id: 41499ece-5964-999d-e063-6394a90ab8fb
spl set id: b57fc6c2-fbfc-24c3-e053-2995a90a3389

Reported adverse events (FAERS/openFDA)#

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