FDA.reportPublic FDA data

Meclizine Hydrochloride

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2021-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:04

Label at a glance#

ProductMeclizine Hydrochloride
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

 Dosage should be taken one hour before travel starts adults and children 12 years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor children under 12 years of age do not give this product to children under 12 years of age unless directed by a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use in

OTC - DO NOT USE SECTION

children under 12 years of age unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

 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 if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking sedatives or tranquilizers

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

 Dosage should be taken one hour before travel starts

adults and children 12
years of age and over 		chew 1 to 2 tablets once daily, or as directed by a doctor
children under
12 years of age 		do not give this product to children under 12 years of age
unless directed by a doctor

Other information

OTHER SAFETY INFORMATION

 Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

 store at room temperature in a dry place

 keep lid tightly closed

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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

*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152
www.rugbylaboratories.com

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count25 mg
3071610-526-30
9071610-526-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20210318JH

PRINCIPAL DISPLAY PANEL - 25 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-526 - Meclizine HCl 25 mg Tablets
Bottle Label 25 mgBottle Label 25 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995632meclizine HCl 25 MG Chewable TabletPSN1
995632meclizine hydrochloride 25 MG Chewable TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-526-302023-01-30C16284748780-1f386c649-c0b0-0266-e053-dadaa90a7c1a5172C- Rubgy
71610-526-602023-01-30C16284748780-1f386c649-c0b0-0266-e053-dadaa90a7c1a5172C- Rubgy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-526-30Meclizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE301
71610-526-60Meclizine Hydrochloride90 in 1 BOTTLETABLET, CHEWABLE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-526MECLIZINE HYDROCHLORIDE TABLET, CHEWABLE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20210320_0a10016e-3fca-476d-b815-fd2abd601918.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-526-30EA - Each71610-526f450295b-b421-49a5-ad29-250a47c8303412021-04-08
71610-526-60EA - Each71610-52638d5a852-da1f-4fea-9964-00f607f2c81d12021-04-08
0536-1299-10EA - Each0536-12994be88e27-d239-44c2-93e3-eb1867badd8212021-02-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71610-52671610-526-30, 71610-526-60
0536-1299

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSPOVIDONE2S7830E561IACT
VANILLAQ74T35078HIACT
MAGNESIUM STEARATE70097M6I30IACT
RASPBERRY4N14V5R27WIACT
STEARIC ACID4ELV7Z65APIACT
FD&C RED NO. 40WZB9127XOAIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDERugby Laboratoriesb57f14a7-3852-03db-e053-2a95a90a80d62026-07-16WarningsExact identifier
ndc (product): 0536-1299
02ea223c-e355-4c27-9e1f-c72276c396830a10016e-3fca-476d-b815-fd2abd6019182021-03-18WarningsExact identifier
spl id: 02ea223c-e355-4c27-9e1f-c72276c39683
spl set id: 0a10016e-3fca-476d-b815-fd2abd601918

Reported adverse events (FAERS/openFDA)#

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