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NDC 71335-0143-02 Meclizine HCl 25 mg 25 mg/1 Details

Meclizine HCl 25 mg 25 mg/1

Meclizine HCl 25 mg is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 71335-0143-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	71335-0143
Product ID	71335-0143_a0d519ec-8a3d-4486-8364-e8ed40bef5cb
Associated GPIs	50200050000510
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Meclizine HCl 25 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine Hydrochloride
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	Bryant Ranch Prepack
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 71335-0143-02 (71335014302)

Pricing Information	N/A
NDC Package Code	71335-0143-2
Billing NDC	71335014302
Package	20 TABLET, CHEWABLE in 1 BOTTLE (71335-0143-2)
Marketing Start Date	2018-03-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a0d519ec-8a3d-4486-8364-e8ed40bef5cb Details

SPL UNCLASSIFIED SECTION

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

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

SPL UNCLASSIFIED SECTION

Purpose

Antiemetic

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Uses

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

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

Do not use in children under 12 years of age unless directed by a doctor.

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have

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

SPL UNCLASSIFIED SECTION

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

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When using this product

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

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Directions

dosage should be taken one hour before travel starts.
adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

SPL UNCLASSIFIED SECTION

Other information

phenylketonurics: contains phenylalanine 0.28 mg per tablet
store at room temperature in a dry place

SPL UNCLASSIFIED SECTION

Inactive ingredients Aspartame, croscarmellose sodium, dextrose, FD&C red #40 lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

SPL UNCLASSIFIED SECTION

Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

HOW SUPPLIED

NDC: 71335-0143-1: 30 Tablets in a BOTTLE

NDC: 71335-0143-2: 20 Tablets in a BOTTLE

NDC: 71335-0143-3: 25 Tablets in a BOTTLE

NDC: 71335-0143-4: 40 Tablets in a BOTTLE

NDC: 71335-0143-5: 60 Tablets in a BOTTLE

NDC: 71335-0143-6: 90 Tablets in a BOTTLE

NDC: 71335-0143-7: 8 Tablets in a BOTTLE

NDC: 71335-0143-8: 14 Tablets in a BOTTLE

NDC: 71335-0143-9: 10 Tablets in a BOTTLE

NDC: 71335-0143-0: 120 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Meclizine 25MG Chewable

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 25 MG

meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0143(NDC:51645-994)
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)
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	pink (Uncoated)	Score	2 pieces
Shape	ROUND (Biconvex)	Size	8mm
Flavor	RASPBERRY	Imprint Code	21G
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0143-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2018
2	NDC:71335-0143-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2018
3	NDC:71335-0143-3	25 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2019
4	NDC:71335-0143-4	40 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2018
5	NDC:71335-0143-5	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
6	NDC:71335-0143-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2018
7	NDC:71335-0143-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2018
8	NDC:71335-0143-8	14 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
9	NDC:71335-0143-9	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
10	NDC:71335-0143-0	120 in 1 BOTTLE; Type 0: Not a Combination Product	03/13/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	10/15/2015

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0143) , RELABEL(71335-0143)

Revised: 2/2022

Document Id: a0d519ec-8a3d-4486-8364-e8ed40bef5cb

Set id: a0d519ec-8a3d-4486-8364-e8ed40bef5cb

Version: 7

Effective Time: 20220209

Search by Drug Name or NDC

NDC 71335-0143-02 Meclizine HCl 25 mg 25 mg/1 Details

Meclizine HCl 25 mg 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-0143-02 (71335014302)

Contents

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HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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