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NDC 61919-0454-30 MECLIZINE HYDROCHLORIDE 25 mg/1 Details

MECLIZINE HYDROCHLORIDE 25 mg/1

MECLIZINE HYDROCHLORIDE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECTRX. 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: 61919-0454-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	61919-0454
Product ID	61919-454_86313229-5407-cd4d-e053-2991aa0a78f3
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 HYDROCHLORIDE
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	DIRECTRX
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 61919-0454-30 (61919045430)

Pricing Information	N/A
NDC Package Code	61919-454-30
Billing NDC	61919045430
Package	30 TABLET, CHEWABLE in 1 BOTTLE (61919-454-30)
Marketing Start Date	2019-04-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 862e048c-eb73-a3b7-e053-2991aa0accf4 Details

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

SPL UNCLASSIFIED SECTION

Antiemetic

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Ask a doctor or pharmacist before use it 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

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.

SPL UNCLASSIFIED SECTION

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

Keep lid tightly closed

SPL UNCLASSIFIED SECTION

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 or comments?

call 1-800-645-2158

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE

meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61919-454(NDC:0536-1018)
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)
SUCROSE (UNII: C151H8M554)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-454-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	04/10/2019

MECLIZINE HCL

meclizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61919-641(NDC:49483-333)
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 in 25

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DEXTROSE (UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
RASPBERRY (UNII: 4N14V5R27W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
VANILLA (UNII: Q74T35078H)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	RASPBERRY	Imprint Code	TCL333
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-641-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	04/10/2019

Labeler - DIRECTRX (079254320)

Name	Address	ID/FEI	Business Operations
Establishment
DIRECTRX		079254320	repack(61919-454, 61919-641)

Revised: 4/2019

Document Id: 86313229-5407-cd4d-e053-2991aa0a78f3

Set id: 862e048c-eb73-a3b7-e053-2991aa0accf4

Version: 2

Effective Time: 20190410

Search by Drug Name or NDC

NDC 61919-0454-30 MECLIZINE HYDROCHLORIDE 25 mg/1 Details

MECLIZINE HYDROCHLORIDE 25 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 61919-0454-30 (61919045430)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 862e048c-eb73-a3b7-e053-2991aa0accf4 Details

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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