Meclizine Hydrochloride

Manufacturer: NORTHEAST PHARMA | GERI-CARE PHARMACEUTICAL CORP
Effective date: 2023-10-26
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:58:08

Label at a glance#

ProductMeclizine Hydrochloride

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Dosage and administration

do not exceed recommended dose 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 tablets once daily or as directed by a doctor

Storage and handling

TAMPER EVIDENT: Do not use if imprinted seal under cap is broken or missing. store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from humidity

Contacts and useful links#

PhoneLabel contact1-800-540-3765

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 the prevention and treatment of these symptoms associated
with motion sickness • nausea • vomiting • dizziness

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

glaucoma
breathing problems, such as emphysema or chronic bronchitis
difficulty urinating due to an enlarged prostate gland

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

alcohol, sedatives, and tranquilizers may increase drowsiness
drowsiness may occur
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 exceed recommended dose
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 tablets once daily or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

TAMPER EVIDENT: Do not use if imprinted seal under cap is broken or missing.
store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995632	meclizine HCl 25 MG Chewable Tablet	PSN	2
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MECLIZINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80136-779-01	Meclizine Hydrochloride	100 in 1 BOTTLE	TABLET, CHEWABLE	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80136-779	MECLIZINE HYDROCHLORIDE (MECLIZINE HCL) TABLET, CHEWABLE [NORTHEAST PHARMA]	2	Legacy NDC, 1 package rows	20231027_eea1e7ec-1cdf-02e3-e053-2a95a90aed44.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Meclizine Hydrochloride
Meclizine HCl
STARCH, CORN
FD&C RED NO. 40
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
SACCHARIN SODIUM
SILICON DIOXIDE
MECLIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80136-779	80136-779-01

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
Name	UNII	Kind
STARCH, CORN	O8232NY3SJ	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
08a175ae-230a-ef8d-e063-6394a90ad234			eea1e7ec-1cdf-02e3-e053-2a95a90aed44	2023-10-26	Warnings	Exact identifier spl id: 08a175ae-230a-ef8d-e063-6394a90ad234 spl set id: eea1e7ec-1cdf-02e3-e053-2a95a90aed44

Reported adverse events (FAERS/openFDA)#

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