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NDC 43063-0804-01 Meclizine 25 25 mg/1 Details

Meclizine 25 25 mg/1

Meclizine 25 is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by PD-Rx 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: 43063-0804-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	43063-0804
Product ID	43063-804_d2bca074-0ebd-0514-e053-2a95a90a36a5
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 25
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	PD-Rx Pharmaceuticals, Inc.
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	n/a

Package

Package Images

NDC 43063-0804-01 (43063080401)

Pricing Information	N/A
NDC Package Code	43063-804-01
Billing NDC	43063080401
Package	100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-804-01)
Marketing Start Date	2018-02-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cf79ac74-017e-4fb4-85d3-4ea944080e89 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each chewable tablet)

Meclizine 25 mg

Purpose

Antiemetic

Indications and Usage

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

Warnings

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

Do not take unless directed by a doctor if you have

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

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

When using this product

do not exceed recommended dosage
drowsiness may occur
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 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

Dosage should be taken 1 hour befor travel starts.

Adults and children 12 years and over:	Take 1 or 2 tablets once daily, or as directed by doctor.

Inactive ingredients

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

Questions?

Adverse drug event call (866) 562-2756 (M-F, 8AM-4PM EST).

How Supplied

Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them.

Supplied in bottles of 6, 12 , 20, 30 and 100 chewable tablets.

PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label

Antiemetic

Each chewable tablet contains:

Meclizine HCl

25 mg

Store at 68°-77°F (20°-25°C)

Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing.

INGREDIENTS AND APPEARANCE

MECLIZINE 25

meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43063-804
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	PH;051
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43063-804-12	12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/27/2017	11/30/2027
2	NDC:43063-804-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/12/2018	11/30/2027
3	NDC:43063-804-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/08/2018	11/30/2027
4	NDC:43063-804-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2018	11/30/2027
5	NDC:43063-804-06	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/23/2018	11/30/2027

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	11/27/2017	11/30/2027

Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)

Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)

Name	Address	ID/FEI	Business Operations
Establishment
PD-Rx Pharmaceuticals, Inc.		156893695	repack(43063-804)

Revised: 12/2021

Document Id: d2bca074-0ebd-0514-e053-2a95a90a36a5

Set id: cf79ac74-017e-4fb4-85d3-4ea944080e89

Version: 12

Effective Time: 20211209