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NDC 24689-0138-01 Meclizine Hydrochloride 12.5 mg/1 Details

Meclizine Hydrochloride 12.5 mg/1

Meclizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by APNAR PHARMA LP. 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: 24689-0138-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	24689-0138
Product ID	24689-138_e4d785a7-a689-3acb-e053-2a95a90a6d2e
Associated GPIs
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 Hydrochloride
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	APNAR PHARMA LP
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M009
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24689-0138-01 (24689013801)

Pricing Information	N/A
NDC Package Code	24689-138-01
Billing NDC	24689013801
Package	100 TABLET in 1 BOTTLE (24689-138-01)
Marketing Start Date	2022-07-29
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e4d785a7-a688-3acb-e053-2a95a90a6d2e Details

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

12.5mg tablet: Meclizine HCL.... 12.5 mg

25mg tablet : Meclizine HCL .....25 mg

SPL UNCLASSIFIED SECTION

Purpose

Antiemetic

SPL UNCLASSIFIED SECTION

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

SPL UNCLASSIFIED SECTION

Directions

Meclizine HCL 12.5mg tablet :

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor

Meclizine HCL 25mg tablet:

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

SPL UNCLASSIFIED SECTION

Inactive Ingredients

Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

SPL UNCLASSIFIED SECTION

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]

SPL UNCLASSIFIED 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 urination due to an enlarged prostate gland

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

If pregnant or breast-feeding,

ask a health professional before use

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

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

SPL UNCLASSIFIED SECTION

Questions or Comments?

Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 05/2022

Made in USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

WARNING

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

PRINCIPAL DISPLAY PANEL

NDC : 24689-138-01

Meclizine Hydrochloride Tablets 12.5 mg

Antiemetic

100 Tablets

NDC : 24689-139-01

Meclizine Hydrochloride Tablets 25 mg

Antiemetic

100 Tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE

meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24689-138
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	A;C4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24689-138-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M009	07/29/2022

MECLIZINE HYDROCHLORIDE

meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24689-139
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

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:24689-139-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M009	07/29/2022

Labeler - APNAR PHARMA LP (079568229)

Name	Address	ID/FEI	Business Operations
Establishment
APNAR PHARMA LLP		118530917	manufacture(24689-138, 24689-139) , analysis(24689-138, 24689-139) , pack(24689-138, 24689-139)

Name	Address	ID/FEI	Business Operations
Establishment
INVAHEALTH INC		116840615	label(24689-138, 24689-139) , pack(24689-138, 24689-139)

Revised: 7/2022

Document Id: e4d785a7-a689-3acb-e053-2a95a90a6d2e

Set id: e4d785a7-a688-3acb-e053-2a95a90a6d2e

Version: 1

Effective Time: 20220728

Search by Drug Name or NDC

NDC 24689-0138-01 Meclizine Hydrochloride 12.5 mg/1 Details

Meclizine Hydrochloride 12.5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 24689-0138-01 (24689013801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL e4d785a7-a688-3acb-e053-2a95a90a6d2e Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

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WARNING

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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