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NDC 16571-0824-10 Meclizine HCl 25 mg/1 Details

Meclizine HCl 25 mg/1

Meclizine HCl is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Rising 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: 16571-0824-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	16571-0824
Product ID	16571-824_448cc004-c7a5-42b0-9a2e-79790e66baa8
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
Proprietary Name Suffix	n/a
Non-Proprietary Name	MECLIZINE HYDROCHLORIDE CHEWABLE
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	Rising 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 16571-0824-10 (16571082410)

Pricing Information
NDC Package Code	16571-824-10
Billing NDC	16571082410
Package	1000 TABLET, CHEWABLE in 1 BOTTLE (16571-824-10)
Marketing Start Date	2022-08-18
NDC Exclude Flag	N
Price Per Unit	0.03227
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	MECLIZINE 25 MG TABLET CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc Details

Drug Facts Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

Purpose

Antiemetic

Uses

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

Warnings

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

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.

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.

Keep out of reach of children.

In case of overdose, get medical help or contact the Poison Control Center immediately.

Directions

Dosage should be taken one hour before travel starts
Adults and children 12 years 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

Other Information

Phenylketonurics: Contains Phenylalanine 0.0025 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

Inactive ingredients

aspartame, colloidal silicon dioxide, croscarmellose sodium, dextrose, lake of FD & C Red 40, magnesium stearate, maltodextrin, microcrystalline cellulose, raspberry flavor, sodium sulfate anhydrous, sucrose, tribasic calcium phosphate

Questions or comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH"SEALED for YOUR PROTECTION" IS BROKEN OR MISSING.Rising Pharma Holdings, Inc. is not affiliated with the owner of the registered trademark Bonine® Manufactured by: Unique Pharmaceutical Laboratories(A Div. of J.B. Chemicals & Pharmaceuticals Ltd.),Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc.East Brunswick, NJ 08816 Mfg. Lic. No.: G/1430Feb 2022

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

Meclizine Hydrochloride Chewable Tablets

25 mg

100 Tablets / 1000 tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HCL

meclizine hydrochloride chewable tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-824
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	pink (Pink to light pink)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	M
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:16571-824-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2022
2	NDC:16571-824-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/18/2022

Labeler - Rising Pharmaceuticals, Inc. (835513529)

Registrant - Unique Pharmaceutical Laboratories (917165052)

Name	Address	ID/FEI	Business Operations
Establishment
Unique Pharmaceutical Laboratories		650434645	manufacture(16571-824)

Revised: 8/2022

Document Id: 448cc004-c7a5-42b0-9a2e-79790e66baa8

Set id: 6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc

Version: 1

Effective Time: 20220818

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NDC 16571-0824-10 Meclizine HCl 25 mg/1 Details

Meclizine HCl 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 16571-0824-10 (16571082410)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6ab6cf0e-a6c9-4b5a-95c1-37c279bf18dc Details

Drug Facts Active ingredient (in each chewable tablet)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

When using this product

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Other Information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

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