Search by Drug Name or NDC

NDC 71610-0528-60 Meclizine HCL 25 mg/1 Details

Meclizine HCL 25 mg/1

Meclizine HCL is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is MECLIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.

Related Packages: 71610-0528-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	71610-0528
Product ID	71610-528_ce757363-1c5a-476b-b373-dd5e7097d56a
Associated GPIs	50200050000510
GCN Sequence Number	004736
GCN Sequence Number Description	meclizine HCl TAB CHEW 25 MG ORAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	18312
HICL Sequence Number	001975
HICL Sequence Number Description	MECLIZINE HCL
Brand/Generic	Generic
Proprietary Name	Meclizine HCL
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCl 25mg Chewable Tablets
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Aphena Pharma Solutions - Tennessee, LLC
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71610-0528-60 (71610052860)

Pricing Information	N/A
NDC Package Code	71610-528-60
Billing NDC	71610052860
Package	90 TABLET, CHEWABLE in 1 BOTTLE (71610-528-60)
Marketing Start Date	2021-03-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 02d1af4d-d97d-4019-a5bf-3ec391238676 Details

Active ingredient

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

Ask a doctor before use if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an elarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increse drowsiness
be careful when driving a moor vehicle or operating machinery

Directions

take dose one hour before travel starts

tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

take 1-2 tablets once daily

children under 12 years:

ask a doctor

Keep out of reach of children.

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

OTHER INFORMATION

Phenylketonurics:

each tablet contains:

phenylalanine 0.28 mg

store at room temparature 15 - 30 °C

Questions or Comments

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

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

Inactive ingredients

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Repackaging Information

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:

Count	25 mg
30	71610-0528-30
90	71610-0528-60

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:

Cookeville, TN 38506

20210415JH

PRINCIPAL DISPLAY PANEL - 25 mg

NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HCL

meclizine hcl 25mg chewable tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71610-528(NDC:54738-025)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
RASPBERRY (UNII: 4N14V5R27W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71610-528-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021
2	NDC:71610-528-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/04/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	05/01/2015

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-528)

Revised: 4/2021

Document Id: ce757363-1c5a-476b-b373-dd5e7097d56a

Set id: 02d1af4d-d97d-4019-a5bf-3ec391238676

Version: 1

Effective Time: 20210415