MECLIZINE

Manufacturer: SDA Laboratories, Inc. | Pharbest Pharmaceuticals, Inc.
Effective date: 2018-02-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:58:58

Label at a glance#

ProductMECLIZINE

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

doage should be taken 1 hour before travel starts Adults and children 12 years and over take 2 or 4 caplets once daily or as directed by doctor

Storage and handling

Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature 20°-25°C (68°-77°F)

Contacts and useful links#

PhoneLabel contact(800) 687-0176

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 12.5mg

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

Do not take unless directed by a doctor if you have

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

Do not take 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
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful 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

doage should be taken 1 hour before travel starts

Adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by doctor

Other information

STORAGE AND HANDLING SECTION

Tamper Evident: do not use if safety seal under cap is broken or missing
store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66424-0386-10

MECLIZINE

Meclizine HCl 12.5mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

SDA

LABORATORIES

SDA Meclizine 12.5 mg Caplet Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	1
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66424-386-01	2022-01-28	C162847	48780-1	d6a99b39-4fff-a426-e053-dadaa90af4c2	Drug Facts
66424-386-10	2022-01-28	C162847	48780-1	d6a99b39-4fff-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66424-386-01	MECLIZINE	100 in 1 BOTTLE, PLASTIC	TABLET	100		1
66424-386-10	MECLIZINE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66424-386	MECLIZINE (MECLIZINE HCL 12.5 MG) TABLET [SDA LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20190324_f2581bc8-7845-4c65-b5cf-fbce48768fb9.zip

Products#

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

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

MECLIZINE
Meclizine HCl 12.5 mg
MECLIZINE HYDROCHLORIDE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66424-386	66424-386-01, 66424-386-10

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
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT

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
01ecb5d8-172e-4a82-8c7e-94e079aacbb1			f2581bc8-7845-4c65-b5cf-fbce48768fb9	2018-02-01	Warnings	Exact identifier spl id: 01ecb5d8-172e-4a82-8c7e-94e079aacbb1 spl set id: f2581bc8-7845-4c65-b5cf-fbce48768fb9

Reported adverse events (FAERS/openFDA)#

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