Meclizine Hydrochloride

Manufacturer: NORTHEAST PHARMA | Geri-Care Pharmaceutical Corp
Effective date: 2023-11-14
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:02:05

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

take the first dose 1/2 hour to 1 hour before starting activity Adults and children 12 years of age and over: Take 1 to 2 tablets once daily, or as directed by a doctor Do not exceed 2 tablets in 24 hours.

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 tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCI 25mg

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

Ask a doctor before use if you have

• breathing problems, such as emphysema or chronic bronchitis

• glaucoma

• difficulty urinating due to an enlarged prostate gland

A sk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product
• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery
I f 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 the first dose 1/2 hour to 1 hour before starting activity
Adults and children 12 years of age and over:

Take 1 to 2 tablets once daily, or as directed by a doctor
Do not exceed 2 tablets in 24 hours.

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

colloidal silicon dioxide, D&C yellow #10 lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995666	meclizine HCl 25 MG Oral Tablet	PSN	2
995666	meclizine hydrochloride 25 MG Oral 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
80136-378-01	Meclizine Hydrochloride	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80136-378	MECLIZINE HYDROCHLORIDE (MECLIZINE HCL) TABLET [NORTHEAST PHARMA]	2	Legacy NDC, 1 package rows	20231115_e3c73fdc-670d-118f-e053-2a95a90a954c.zip

Products#

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

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

Meclizine Hydrochloride
Meclizine HCl
LACTOSE MONOHYDRATE
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
D&C YELLOW NO. 10 ALUMINUM LAKE
MECLIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80136-378	80136-378-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
D&C YELLOW NO. 10 ALUMINUM LAKE	CQ3XH3DET6	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
0a20bfde-2901-285a-e063-6394a90a02b8			e3c73fdc-670d-118f-e053-2a95a90a954c	2023-11-14	Warnings	Exact identifier spl id: 0a20bfde-2901-285a-e063-6394a90a02b8 spl set id: e3c73fdc-670d-118f-e053-2a95a90a954c

Reported adverse events (FAERS/openFDA)#

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