MECLIZINE

Manufacturer: NuCare Pharmaceuticals,Inc.
Effective date: 2021-02-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 22:51:25

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 1 or 2 tablets 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 tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 25mg

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 1 or 2 tablets 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, dextrose, FD&C Red#40, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-4986-6	2024-06-18	C162847	48780-1	ba0f9c33-45a2-a910-e053-dadaa90a0b85	Drug Facts
68071-4986-6	2023-01-30	C162847	48780-1	ba0f9c33-45a2-a910-e053-dadaa90a0b85	Drug Facts
68071-4986-6	2021-02-19	C162847	48780-1	ba0f9c33-45a2-a910-e053-dadaa90a0b85	Drug Facts
68071-4986-6	2021-01-29	C162847	48780-1	ba0f9c33-45a2-a910-e053-dadaa90a0b85	Drug Facts

Products#

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

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

MECLIZINE
Meclizine HCl 25mg
CROSCARMELLOSE SODIUM
DEXTROSE
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SACCHARIN SODIUM
STEARIC ACID
MECLIZINE HYDROCHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68071-4986	68071-4986-6
66424-387

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
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
DEXTROSE	IY9XDZ35W2	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MECLIZINE HYDROCHLORIDE	HDP7W44CIO	ACTIB

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
1b2ebfe0-a824-d3c7-e063-6394a90a470c			8e740b03-931f-aa25-e053-2a95a90ac95b	2024-06-18	Warnings	Exact identifier spl set id: 8e740b03-931f-aa25-e053-2a95a90ac95b

Reported adverse events (FAERS/openFDA)#

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