MECLIZINE

Manufacturer: Pharbest Pharmaceuticals, Inc.
Effective date: 2025-12-24
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 01:28:34

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

dosage 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 each caplet contains: calcium 28 mg store at 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

Contacts and useful links#

PhonePoison Help(800-222-1222

PhoneLabel contact(866) 562-2756

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 this product, 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 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

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 (800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

dosage 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
each caplet contains: calcium 28 mg
store at 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri, 8 AM to 4 PM EST).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-386-08

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 CAPLETS

Meclizine 12.5 mg caplet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	3
995624	meclizine hydrochloride 12.5 MG Oral 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-386-08	2024-12-31	C162847	48780-1	d6a99b39-35a2-a426-e053-dadaa90af4c2	Drug Facts
16103-386-11	2024-12-31	C162847	48780-1	d6a99b39-35a2-a426-e053-dadaa90af4c2	Drug Facts
16103-386-08	2022-01-28	C162847	48780-1	d6a99b39-35a2-a426-e053-dadaa90af4c2	Drug Facts
16103-386-11	2022-01-28	C162847	48780-1	d6a99b39-35a2-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16103-386-08	MECLIZINE	100 in 1 BOTTLE, PLASTIC	TABLET	100		3
16103-386-11	MECLIZINE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16103-386-08	EA - Each	16103-386	2154668d-662d-47cf-bbf1-5bb5c63c750d	1	2019-04-11
16103-386-11	EA - Each	16103-386	51f253cb-57da-41ee-bc3e-9f303e042a0e	1	2019-04-11

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
16103-386	16103-386-08, 16103-386-11

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
MECLIZINE	MECLIZINE HCL 12.5 MG	Pharbest Pharmaceuticals, Inc.	8b3c9283-b618-4d57-9f15-7cf73e8737f5	2025-12-24	Warnings	Exact identifier ndc (package): 16103-386-08 ndc (package): 16103-386-11 ndc (product): 16103-386 ndc11 (package): 16103038611 ndc11 (package): 16103038608 spl id: d7d81436-c338-4988-bf9e-a721e0cb8f91 spl set id: 8b3c9283-b618-4d57-9f15-7cf73e8737f5

Reported adverse events (FAERS/openFDA)#

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