MECLIZINE HYDROCHLORIDE TABLETS, USP 12.5 mg

Manufacturer: BluePoint Laboratories | Unique Pharmaceutical Laboratories
Effective date: 2023-11-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:02:26

Label at a glance#

ProductMeclizine HCl

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure14 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Dosage and administration

dosage should be taken one hour before travel starts adults and children 12 years and over take 2 or 4 tablets once daily or as directed by a doctor

Storage and handling

store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-474-7464

Label contents#

Full prescribing information#

Drug Facts Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl, USP 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Warnings

WARNINGS SECTION

Do not use in children under 12 years of age unless directed by a doctor.

WARNINGS SECTION

Do not take this product, unless directed by a doctor, if you have

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

WARNINGS SECTION

Do not take this product if you are

taking sedatives or tranquilizers,

without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution 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.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

dosage should be taken one hour before travel starts


adults and children 12 years and over	take 2 or 4 tablets once daily or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-528-00

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	2
995624	meclizine hydrochloride 12.5 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
68001-528-00	Meclizine HCl	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
68001-528	MECLIZINE HCL (MECLIZINE HYDROCHLORIDE) TABLET [BLUEPOINT LABORATORIES]	2	Current NDC, Legacy NDC, 1 package rows	20231118_d9cae5a6-8d4b-bdaf-e053-2995a90a7d44.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-528-00	EA - Each	68001-528	2946ba4e-e8da-44a9-b239-df3aa92349e7	1	2022-04-06

Products#

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

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

Meclizine HCl
MECLIZINE HYDROCHLORIDE
SILICON DIOXIDE
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
MECLIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68001-528	68001-528-00

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
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSPOVIDONE	2S7830E561	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	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
Meclizine HCl	MECLIZINE HYDROCHLORIDE	BluePoint Laboratories	d9cae5a6-8d4b-bdaf-e053-2995a90a7d44	2023-11-17	Warnings	Exact identifier ndc (package): 68001-528-00 ndc (product): 68001-528 ndc11 (package): 68001052800 spl id: 097bfb09-4450-bd70-e063-6294a90a91b7 spl set id: d9cae5a6-8d4b-bdaf-e053-2995a90a7d44

Reported adverse events (FAERS/openFDA)#

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