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NDC 16103-0387-08 MECLIZINE 25 mg/1 Details

MECLIZINE 25 mg/1

MECLIZINE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Pharbest Pharmaceuticals, 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: 16103-0387-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	16103-0387
Product ID	16103-387_887b312d-3c2c-4dcb-86eb-316dfb068bc9
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCl 25mg
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	Pharbest Pharmaceuticals, Inc.
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 16103-0387-08 (16103038708)

Pricing Information	N/A
NDC Package Code	16103-387-08
Billing NDC	16103038708
Package	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16103-387-08)
Marketing Start Date	2018-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4bac2765-045c-405e-8006-8c5cfdfa89bc Details

Active ingredient (in each tablet)

Meclizine HCl 25mg

Purpose

Antiemetic

Uses

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

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

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.

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)

Directions

doage should be taken one hour before travel starts

Adults and children 12 years and over	take 1 or 2 tablets once daily or as directed by doctor

Other information

Tamper Evident: do not use if safety seal under cap is broken or missing
store at 20°-25°C (68°-77°F)

Inactive ingredients

Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

(866) 562-2756 (Mon - Fri, 8AM - 4PM EST)

PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

*Compare to the active ingredient in Bonine®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 TABLETS

INGREDIENTS AND APPEARANCE

MECLIZINE

meclizine hcl 25mg tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16103-387
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
RASPBERRY (UNII: 4N14V5R27W)

Product Characteristics
Color	pink (LIGHT PINK COLOR)	Score	2 pieces
Shape	ROUND (ROUND TABLET)	Size	8mm
Flavor		Imprint Code	PH051
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:16103-387-08	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018
2	NDC:16103-387-11	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	02/01/2018

Labeler - Pharbest Pharmaceuticals, Inc. (557054835)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(16103-387) , pack(16103-387) , analysis(16103-387) , label(16103-387)

Revised: 4/2022

Document Id: 887b312d-3c2c-4dcb-86eb-316dfb068bc9

Set id: 4bac2765-045c-405e-8006-8c5cfdfa89bc

Version: 2

Effective Time: 20220408