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NDC 71205-0606-30 Meclizine HCL 25 mg 25 mg/1 Details

Meclizine HCL 25 mg 25 mg/1

Meclizine HCL 25 mg is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx 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: 71205-0606-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	71205-0606
Product ID	71205-606_15ddaaca-bd8f-4bf3-8b65-db03ba69cc85
Associated GPIs
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 25 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
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 71205-0606-30 (71205060630)

Pricing Information	N/A
NDC Package Code	71205-606-30
Billing NDC	71205060630
Package	30 TABLET in 1 BOTTLE, PLASTIC (71205-606-30)
Marketing Start Date	2021-09-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d08fa6f5-4293-4468-814e-7dccbd281209 Details

Drug Facts

Active ingredient (in each tablet)

Meclizine HCL 25 mg

Purpose

Antiemetic

Uses

•: prevents and treats nausea, vomiting or dizziness due to motion sickness
•: for others 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 enlarged prostate gland

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

When using this prodcut

•: you may get drowsy
•: avoid alcoholic drinks
•: alcohol, sedatives and tranquilizers may increase drowsiness
•: be careful when driving a motor vehicle or operating machinery

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 right away.

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

SPL UNCLASSIFIED SECTION

When using this product

•: you may get drowsy
•: avoid alcoholic drinks
•: alcohol, sedatives and tranquilizers may increase drowsiness
•: be careful 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 a Poison Control Center right away.

Directions

•: take dose one hour before travel starts
•: tablets can be chewed or swallowed whole with water

adults & children 12 years and over: 1-2 tablets once daily

children unser 12 years: ask a doctor

Other information

•: Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
•: store at room temperature 15°-30°C (59°-86°F)
•: This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC 71205-606-30

Meclizine HCL 25 mg

ANTIEMETIC

30 TABLETS

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

*Compare to Active Ingredient in BONINE®

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 25 MG

meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-606(NDC:69618-028)
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
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
ASPARTAME (UNII: Z0H242BBR1)
SUCROSE (UNII: C151H8M554)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	pink (Light Raspberry color)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-606-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2021
2	NDC:71205-606-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2021
3	NDC:71205-606-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/14/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	11/01/2015

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(71205-606) , RELABEL(71205-606)

Revised: 6/2022

Document Id: 15ddaaca-bd8f-4bf3-8b65-db03ba69cc85

Set id: d08fa6f5-4293-4468-814e-7dccbd281209

Version: 2

Effective Time: 20220601

Search by Drug Name or NDC

NDC 71205-0606-30 Meclizine HCL 25 mg 25 mg/1 Details

Meclizine HCL 25 mg 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71205-0606-30 (71205060630)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d08fa6f5-4293-4468-814e-7dccbd281209 Details

Drug Facts

Active ingredient (in each tablet)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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