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NDC 69842-0395-54 Motion Sickness Relief 25 mg/1 Details

Motion Sickness Relief 25 mg/1

Motion Sickness Relief is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY, 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: 69842-0395-54
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	69842-0395
Product ID	69842-395_05742d9a-1a56-4982-b872-366f86091bbb
Associated GPIs
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	Motion Sickness Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCl
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	CVS PHARMACY, 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 69842-0395-54 (69842039554)

Pricing Information	N/A
NDC Package Code	69842-395-54
Billing NDC	69842039554
Package	15 POUCH in 1 CARTON (69842-395-54) / 2 TABLET, CHEWABLE in 1 POUCH
Marketing Start Date	2017-11-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL eb137393-889c-4498-95cd-6c0e6e126c5f Details

Active ingredient (in each tablet)

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

for prevention and treatment of these symptoms associated with motion sickness:

nausea
vomiting
dizziness

Warnings

Do not use

for children under 12 years of age unless directed by a doctor

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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 product

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 a doctor before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

take first dose one hour before starting activity
adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor

Other information

Phenylketonurics: each tablet contains: phenylalanine 0.28 mg
store at room temperature 15º - 30ºC (59º - 86ºF)

Inactive ingredients

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

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Motion Sickness Relief

30 Tablets 15 Pouches (2 Tablets per Pouch)

NDC 69842-395-54

INGREDIENTS AND APPEARANCE

MOTION SICKNESS RELIEF

meclizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-395
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)
RASPBERRY (UNII: 4N14V5R27W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-395-54	15 in 1 CARTON	11/28/2017
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	11/28/2017

Labeler - CVS PHARMACY, INC. (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(69842-395)

Revised: 11/2017

Document Id: 05742d9a-1a56-4982-b872-366f86091bbb

Set id: eb137393-889c-4498-95cd-6c0e6e126c5f

Version: 1

Effective Time: 20171128