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 22:37:10

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

• 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

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

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, lactose, Raspberry flavor, FD&C Red #40 lake, starch, sodium saccharin, and dextrates hydrated.

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 Chewable Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 13811-648-10

Meclizine HCl
25 mg

100 CHEWABLE TABLETS

TRIGEN
LABORATORIES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995632	meclizine HCl 25 MG Chewable Tablet	PSN	1
995632	meclizine hydrochloride 25 MG Chewable 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
13811-648-01	2020-01-31	C162847	48780-1	9d75b9d0-b05f-f424-e053-dadaa90a57ce	DRUG FACTS
13811-648-10	2020-01-31	C162847	48780-1	9d75b9d0-b05f-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13811-648-01	Meclizine HCl	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000		1
13811-648-10	Meclizine HCl	100 in 1 BOTTLE	TABLET, CHEWABLE	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13811-648	MECLIZINE HCL (MECLIZINE HYDROCHLORIDE CHEWABLE TABLETS) TABLET, CHEWABLE [TRIGEN LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131008_ccab7b75-29c0-4024-a4a0-e506732e56ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13811-648-01	EA - Each	13811-648	b4e28174-cf4b-4224-b051-2dc87739d1d8	1	2013-12-02
13811-648-10	EA - Each	13811-648	7bdae128-3c69-4aa3-a4bc-8933353daddd	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
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1

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 CHEWABLE TABLETS
MECLIZINE HYDROCHLORIDE
MECLIZINE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
LACTOSE
FD&C RED NO. 40
STARCH, CORN
SACCHARIN SODIUM
DEXTRATES

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13811-648	13811-648-10, 13811-648-01
57631-009

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
LACTOSE	J2B2A4N98G	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
STARCH, CORN	O8232NY3SJ	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
DEXTRATES	G263MI44RU	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 · 195 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 / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / DENTAL	0.05 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 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
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 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
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / RECTAL	0.6 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 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	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
DEXTRATES	DEXTRATES	G263MI44RU	TABLET, ORALLY DISINTEGRATING / ORAL		311 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		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
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
DEXTRATES	DEXTRATES	G263MI44RU	TABLET / ORAL		437 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 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
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 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	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 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, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 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
79a4bd44-386d-4756-b772-d60c0c3be05c			ccab7b75-29c0-4024-a4a0-e506732e56ab	2013-09-15	Warnings	Exact identifier spl id: 79a4bd44-386d-4756-b772-d60c0c3be05c spl set id: ccab7b75-29c0-4024-a4a0-e506732e56ab

Reported adverse events (FAERS/openFDA)#

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