MECLIZINE HCL

Manufacturer
DIRECTRX
Effective date
2019-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:26:16

Label at a glance#

ProductMECLIZINE HYDROCHLORIDE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

Other information Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet Store at room temperature in a dry place Keep lid tightly closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

OTC - PURPOSE SECTION


Antiemetic

INDICATIONS & USAGE SECTION


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

WARNINGS SECTION

Warnings

Do not use in children under 12 years of age unless directed by a doctor

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 it you are taking sedatives or tranquilizers.

When using this product

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, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact the poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Dosage should be taken one hour before travel starts
Adults and children 12 years of age and older: Chew 1-2 tablets once daily, or as directed by a doctor
Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

STORAGE AND HANDLING SECTION

Other information

Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

INACTIVE INGREDIENT SECTION


aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

OTC - QUESTIONS SECTION

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of overdose, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

454.30454.30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

641-20641-20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-454-30EA - Each61919-454a1ec0bad-23ba-4f93-9a71-b8ffb9238afa12019-04-11
61919-641-20EA - Each61919-64185a6756c-d286-4fad-bc48-92c7cf8430ec12019-04-11
0536-1018-01EA - Each0536-101838974734-0ca3-472f-a497-87a548eaec9412014-09-03
0536-1018-10EA - Each0536-1018f375fa7f-4c57-4dd0-8d08-870621e0e1e712014-10-03
49483-333-01EA - Each49483-3335957c9df-76dd-47c7-ace2-e934cba6452012015-10-02
49483-333-10EA - Each49483-3339dd91377-941f-482b-8de6-82ccff7eae6812014-11-05
49483-333-16EA - Each49483-333718164ca-5635-48af-8f0d-a755a997b94912015-10-02

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-45461919-454-30
61919-64161919-641-20
0536-1018
49483-333

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0711ce37-abca-4be4-e063-6394a90a29b4862e048c-eb73-a3b7-e053-2991aa0accf42023-10-06WarningsExact identifier
spl set id: 862e048c-eb73-a3b7-e053-2991aa0accf4
Motion-Time ChewableMECLIZINE HCLTime-Cap Labs, Inc7f3ce1e6-c0d6-4b56-8f7a-6368eb46901f2018-12-17WarningsExact identifier
ndc (product): 49483-333

Reported adverse events (FAERS/openFDA)#

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