Meclizine HCl

Manufacturer
NORTHEAST PHARMA | Geri-Care Pharmaceutical Corp
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:02:15

Label at a glance#

ProductMeclizine HCl
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Dosage and administration

to prevent motion sickness, take the first dose 1/2 to 1 hour before starting activity not for frequent or prolonged use except on the advice of a doctor Adults and children 12 years of age and over: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Storage and handling

• TAMPER EVIDENT: Do not use if imprinted seal under cap is broken or missing. • store at room temperature 15˚-30˚C (59˚-86˚F) • protect from humidity

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCI 25mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

• breathing problems, such as emphysema or chronic bronchitis

• glaucoma

• difficulty urinating due to an enlarged prostate gland

A sk a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

• drowsiness may occur

• avoid alcoholic beverages

• alcohol, sedatives and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery
I f pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • to prevent motion sickness, take the first

dose 1/2 to 1 hour before starting activity

  • not for frequent or prolonged use except on the advice of a doctor
  • Adults and children 12 years of age and over: Take 1-2
    tablets once daily, or as directed by a doctor.
    Do not exceed 2 tablets in 24 hours.

Other information

STORAGE AND HANDLING SECTION

• TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

• store at room temperature 15˚-30˚C (59˚-86˚F)

• protect from humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10 lake,
lactose, magnesium stearate, microcrystalline
cellulose, silica, sodium starch glycolate, starch.

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80136-77880136-778-01

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d22f3949-61a8-d705-e053-2a95a90a0447b622b39e-99ad-3cbc-e053-2995a90a22b62021-12-02WarningsExact identifier
spl set id: b622b39e-99ad-3cbc-e053-2995a90a22b6

Reported adverse events (FAERS/openFDA)#

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