Meclizine Hydrochloride Tablets

Manufacturer
Rising Pharma Holdings, Inc. | Aurex Laboratories Limited Liability Company
Effective date
2022-10-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:51:52

Label at a glance#

ProductMeclizine HCl
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Dosage and administration

dosage should be taken one hour before travel starts for 25 mg: adults and children 12 years and over, take 1 or 2 tablets once daily or directed by a doctor for 12.5 mg: adults and children 12 years and over, take 2 or 4 tablets once daily or directed by a doctor

Label contents#

Full prescribing information#

Drug FactsActive ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

12.5 mg Tablet: Meclizine HCl    12.5 mg

25 mg Tablet: Meclizine HCl     25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dosage should be taken one hour before travel starts

for 25 mg: adults and children 12 years and over, take 1 or 2 tablets once daily or directed by a doctor

for 12.5 mg: adults and children 12 years and over, take 2 or 4 tablets once daily or directed by a doctor

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

magnesium sterate, microcrystalline cellulose, silicon dioxide, lactose monohydrate

Other Information

SPL UNCLASSIFIED SECTION

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-844-474-7464

Warnings

WARNINGS SECTION

Do not use in 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
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

OTC - DO NOT USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 immediately (1-800-222-1222).

Manufactured by:

Aurex laboratories LLC
East Windsor, NJ 08520

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Revised:08/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCl Tablets

25 mg

100

meclizine-25mg-frontmeclizine-25mg-front

meclizine-25mg-backmeclizine-25mg-back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCl Tablets

12.5 mg

100

meclizine-12.5mgmeclizine-12.5mg

meclizine-12.5mg-backmeclizine-12.5mg-back

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-751-01EA - Each16571-751e9775eea-36e1-40ca-8dbb-119b3f803cd512023-05-05
16571-752-01EA - Each16571-7522aa5cc45-df03-424f-8cab-224a4103476212023-05-05

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16571-75116571-751-01
16571-75216571-752-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
5955ab7d-5927-4092-91ed-fa9b21b86b1a7f375ef7-1bb7-412f-b097-0d350e27dbf82023-07-12WarningsExact identifier
spl set id: 7f375ef7-1bb7-412f-b097-0d350e27dbf8

Reported adverse events (FAERS/openFDA)#

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