FDA.reportPublic FDA data

CVS 44-404A-Motion Sickness

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-19 01:01:06

Label at a glance#

ProductMotion Sickness
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Dosage and administration

do not take more than directed dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from heat and humidity see end flap for expiration date and lot number 

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • dosage should be taken one hour before travel starts
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from heat and humidity
  • see end flap for expiration date and lot number 

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, saccharin sodium, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥︎CVS™

51316-441-21

UP TO
24
HR

actual size

Raspberry 
Flavor

MOTION SICKNESS

Meclizine Hydrochloride, 25 mg Chewable Tablets, Antiemetic

Helps prevent nausea, vomiting       |    Ages 12 Years
& dizziness due to motion sickness  |     & Over

16 CHEWABLE
TABLETS
(25 mg EACH)

Compare to Bonine®
Chewable Tablets
active ingredient*

Chew or crush tablets
completely before
swallowing. Do not swallow
tablets whole.

CVS 44-404A
CVS 44-404A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

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
51316-44151316-441-21

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
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-09-26full-release2026-06-01 01:14:57

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
72aa71d3-987f-4477-b50a-b25e49f4c249740a82ec-000a-480e-82bf-1bfb8fd0ff902025-09-26WarningsExact identifier
spl set id: 740a82ec-000a-480e-82bf-1bfb8fd0ff90

Reported adverse events (FAERS/openFDA)#

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