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NDC 16571-0751-01 Meclizine HCl 12.5 mg/1 Details

Meclizine HCl 12.5 mg/1

Meclizine HCl is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. 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: 16571-0751-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	16571-0751
Product ID	16571-751_07ba5b50-4b9f-4ddb-90de-f84bec613344
Associated GPIs	50200050000305
GCN Sequence Number	004731
GCN Sequence Number Description	meclizine HCl TABLET 12.5 MG ORAL
HIC3	H6J
HIC3 Description	ANTIEMETIC/ANTIVERTIGO AGENTS
GCN	18301
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 HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Rising Pharma Holdings, Inc.
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2023-12-31

Package

Package Images

NDC 16571-0751-01 (16571075101)

Pricing Information
NDC Package Code	16571-751-01
Billing NDC	16571075101
Package	100 TABLET in 1 BOTTLE (16571-751-01)
Marketing Start Date	2021-08-17
NDC Exclude Flag	N
Price Per Unit	0.03185
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	MECLIZINE 12.5 MG TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 7f375ef7-1bb7-412f-b097-0d350e27dbf8 Details

Drug Facts Active ingredient (in each tablet)

12.5 mg Tablet: Meclizine HCl 12.5 mg

25 mg Tablet: Meclizine HCl 25 mg

SPL UNCLASSIFIED SECTION

Purpose

Antiemetic

Uses

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

Directions

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

magnesium sterate, microcrystalline cellulose, silicon dioxide, lactose monohydrate

Other Information

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?

Call 1-844-474-7464

Warnings

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

SPL UNCLASSIFIED SECTION

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

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

SPL UNCLASSIFIED SECTION

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 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

PRINCIPAL DISPLAY PANEL

Meclizine HCl Tablets

25 mg

100

PRINCIPAL DISPLAY PANEL

Meclizine HCl Tablets

12.5 mg

100

INGREDIENTS AND APPEARANCE

MECLIZINE HCL

meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-751
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (White to off white)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	A;C4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16571-751-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/17/2021

MECLIZINE HCL

meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-752
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	AM7
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16571-752-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/17/2021

Labeler - Rising Pharma Holdings, Inc. (835513529)

Registrant - Aurex Laboratories Limited Liability Company (067585317)

Name	Address	ID/FEI	Business Operations
Establishment
Aurex Laboratories Limited Liability Company		067585317	manufacture(16571-751, 16571-752) , pack(16571-751, 16571-752) , analysis(16571-751, 16571-752) , label(16571-751, 16571-752)

Revised: 10/2022

Document Id: 07ba5b50-4b9f-4ddb-90de-f84bec613344

Set id: 7f375ef7-1bb7-412f-b097-0d350e27dbf8

Version: 1

Effective Time: 20221007

Search by Drug Name or NDC

NDC 16571-0751-01 Meclizine HCl 12.5 mg/1 Details

Meclizine HCl 12.5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 16571-0751-01 (16571075101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7f375ef7-1bb7-412f-b097-0d350e27dbf8 Details

Drug Facts Active ingredient (in each tablet)

SPL UNCLASSIFIED SECTION

Uses

Directions

Inactive Ingredients

Other Information

Questions or Comments?

Warnings

SPL UNCLASSIFIED SECTION

When using this product

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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