Meclizine HCl

Manufacturer: Aidarex Pharmaceuticals LLC
Effective date: 2014-01-12
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:38:13

Label at a glance#

ProductMeclizine HCl

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

prevents and treats nausea, vomiting, or dizziness due to motion sickness

Dosage and administration

take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: 1-2 tablets once daily children under 12 years: ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-645-2158

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting, or dizziness due to motion sickness

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives & tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding, ask a health professional before use.

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 dose one hour before travel starts
tablets can be chewed or swallowed whole with water
adults & children 12 years and over: 1-2 tablets once daily
children under 12 years: ask a doctor

Other Information

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

phenylketonurics: each tablet contains: phenylalanine 0.28mg
store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Rugby® Duluth, Georgia 30097

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCl

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 33261-0413-30

30 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995632	meclizine HCl 25 MG Chewable Tablet	PSN	3
995632	meclizine hydrochloride 25 MG Chewable Tablet	SCD	3

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
33261-413-30	2020-01-31	C162847	48780-1	9d75b9d1-24cc-f424-e053-dadaa90a57ce	Travel Sickness
33261-413-60	2020-01-31	C162847	48780-1	9d75b9d1-24cc-f424-e053-dadaa90a57ce	Travel Sickness

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-413-30	Meclizine HCl	30 in 1 BOTTLE, PLASTIC	TABLET	30		3
33261-413-60	Meclizine HCl	60 in 1 BOTTLE, PLASTIC	TABLET	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-413	MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 2 package rows	20140128_cf1332f0-8662-45ed-a76f-3e620f60f05b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-413-30	EA - Each	33261-413	c890ff60-2d35-4426-8355-f60b26b7f0bd	1	2015-10-02
33261-413-60	EA - Each	33261-413	b5e34f47-efcb-49e9-9df5-8b4c0717a9df	1	2015-10-02
0536-3990-01	EA - Each	0536-3990	19e21193-3400-4ae7-bfeb-be4e3be3b03e	1	2013-02-13
0536-3990-10	EA - Each	0536-3990	037f1ac0-8bb3-4253-9b4f-210bfa1a8b63	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	3
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	3
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	3
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Meclizine HCl
MECLIZINE HYDROCHLORIDE
MECLIZINE
CROSCARMELLOSE SODIUM
ASPARTAME
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SUCROSE
DEXTROSE
FD&C RED NO. 40
RASPBERRY

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
33261-413	33261-413-30, 33261-413-60
0536-3990

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
Name	UNII	Kind
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
ASPARTAME	Z0H242BBR1	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SUCROSE	C151H8M554	IACT
DEXTROSE	IY9XDZ35W2	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
RASPBERRY	4N14V5R27W	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 205 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET, COATED / ORAL	132 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	SOLUTION / ORAL	2489 mg/5ml		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	SOLUTION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	PASTILLE / ORAL	826 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SOLUTION / ORAL	233 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TABLET / SUBLINGUAL	115.78 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	TROCHE / ORAL	903.5 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TROCHE / ORAL		50 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	POWDER, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	FILM, EXTENDED RELEASE / BUCCAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING / ORAL		180 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTROSE	DEXTROSE	IY9XDZ35W2	INJECTION, SOLUTION / INTRAVENOUS	51.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		78 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates

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
433935fb-4377-4c68-9fd8-b127bf281095			cf1332f0-8662-45ed-a76f-3e620f60f05b	2014-01-12	Warnings	Exact identifier spl id: 433935fb-4377-4c68-9fd8-b127bf281095 spl set id: cf1332f0-8662-45ed-a76f-3e620f60f05b

Reported adverse events (FAERS/openFDA)#

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