Meclizine HCl

Manufacturer: Trigen Laboratories, Inc. | Trigen Laboratories, Inc..
Effective date: 2013-09-15
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:37:09

Label at a glance#

ProductMeclizine HCl

Active ingredientMECLIZINE HYDROCHLORIDE

Label structure13 sections

Indications and uses

prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.

Dosage and administration

• Adults & children 12 years and over: 2-4 tablet once daily • Children under 12 years: ask a doctor

Storage and handling

• each tablet contains: calcium 51 mg • Store at room temperature 15°-30°C (59°-86°F)

Contacts and useful links#

Websitewww.trigenlab.com

www.trigenlab.com

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses:

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.

WARNING: Ask a doctor before use if you have

WARNINGS SECTION

• Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Trouble urinating due to an enlarged prostate gland.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using product

OTC - WHEN USING SECTION

• You may get drowsy • Avoid alcoholic drinks • Alcohol, sedatives and tranquilizers may increase drowsiness • Be careful when driving a motor vehicle or operating machinery

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a Physician 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

• Adults & children 12 years and over: 2-4 tablet once daily

• Children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

• each tablet contains: calcium 51 mg

• Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline cellulose, magnesium stearate, sodium starch glycolate, crospovidone, talc, and lactose.

SPL UNCLASSIFIED SECTION

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

TRIGEN
LABORATORIES

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 08/13

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13811-647-10

Meclizine HCl
25 mg

100 TABLETS

TRIGEN
LABORATORIES

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 08/13

PRINCIPAL DISPLAY PANEL - 25 mg - 100 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995666	meclizine HCl 25 MG Oral Tablet	PSN	1
995666	meclizine hydrochloride 25 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
13811-647-01	2020-01-31	C162847	48780-1	9d75b9d1-0798-f424-e053-dadaa90a57ce	DRUG FACTS
13811-647-10	2020-01-31	C162847	48780-1	9d75b9d1-0798-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13811-647-01	Meclizine HCl	1000 in 1 BOTTLE	TABLET	1000		1
13811-647-10	Meclizine HCl	100 in 1 BOTTLE	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13811-647	MECLIZINE HCL (MECLIZINE HYDROCHLORIDE TABLETS) TABLET [TRIGEN LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131008_6c645ead-95fe-49e8-b38b-25ed1bba1c03.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13811-647-01	EA - Each	13811-647	c2c68ffb-79c7-4038-b049-77512aa54001	1	2013-12-02
13811-647-10	EA - Each	13811-647	5f00d73f-8198-4e9a-ad93-b23f652e35cc	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MECLIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	HDP7W44CIO	1
MECLIZINE	ACTIVE MOIETY	3L5TQ84570	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	1
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Meclizine HCl
MECLIZINE HYDROCHLORIDE TABLETS
MECLIZINE HYDROCHLORIDE
MECLIZINE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A CORN
POVIDONE K30
TALC
LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13811-647	13811-647-10, 13811-647-01
57631-008

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
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
POVIDONE K30	U725QWY32X	IACT
TALC	7SEV7J4R1U	IACT
LACTOSE	J2B2A4N98G	IACT

Source Document#

Source XML · Source PDF

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 3 · 178 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SUSPENSION / ORAL		148 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 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
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, FOR SUSPENSION / ORAL		462 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE / ORAL		540 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, DELAYED RELEASE / ORAL		516 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	POWDER / ORAL		378 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SYSTEM / TRANSDERMAL		15 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	AEROSOL, FOAM / TOPICAL	1.9 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	SOLUTION/ DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL		2828 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	FILM, EXTENDED RELEASE / TRANSDERMAL		16 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	GRANULE / ORAL		202 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, ORALLY DISINTEGRATING / ORAL		71 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION / ORAL		234 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET, EXTENDED RELEASE / ORAL		368 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, COATED, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 40 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
cdc36345-d71d-43f7-bc03-0738c6f1ebaa			6c645ead-95fe-49e8-b38b-25ed1bba1c03	2013-09-15	Warnings	Exact identifier spl id: cdc36345-d71d-43f7-bc03-0738c6f1ebaa spl set id: 6c645ead-95fe-49e8-b38b-25ed1bba1c03

Reported adverse events (FAERS/openFDA)#

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