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NDC 50804-0620-08 Motion sickness 25 mg/1 Details

Motion sickness 25 mg/1

Motion sickness is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, 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: 50804-0620-08
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	50804-0620
Product ID	50804-620_2c0e4942-17ab-47f2-a2d0-d1336b636f8b
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
Proprietary Name Suffix	less drowsy formula
Non-Proprietary Name	Meclizine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	25
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Good Sense (Geiss, Destin & Dunn, 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 50804-0620-08 (50804062008)

Pricing Information	N/A
NDC Package Code	50804-620-08
Billing NDC	50804062008
Package	1 BLISTER PACK in 1 CARTON (50804-620-08) / 8 TABLET in 1 BLISTER PACK
Marketing Start Date	2012-03-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a3b8b125-e058-482c-8a02-5bc5bd957447 Details

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

for prevention and treatment nausea, vomiting, or dizziness associated with motion sickness

Warnings

Do not use

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

Ask a doctor before use if you have

breathing problems such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to an enlargement of the 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 beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children

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

Directions

To prevent motion sickness, the first dose should be taken 1 hour before starting activity
adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor
do not exceed 2 tablets in 24 hours

Other information

store at room temperature 20o- 30o C (68o- 86o F)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C Yellow# 10 Aluminium lake, magnesium stearate, microcrystalline cellulose sodium starch glycolate.

Questions or Comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Less Drowsy Formula

MOTION SICKNESS II Tablets

Prevents up to 24 hours of Motion Sickness
Protection with less drowsiness

Meclizine HCI, 25mg

Antiemetic

Tablets

*Compare to active ingredient in Dramamine® Less Drowsy Formula

*This product is not manufactured or distributed by Prestige Brand, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree city, GA 30269

www.valuelabel.com

Product Label

GoodSense Less Drowsy Formula Motion Sickness II

INGREDIENTS AND APPEARANCE

MOTION SICKNESS LESS DROWSY FORMULA

meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-620
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white, yellow	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL086
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-620-08	1 in 1 CARTON	03/19/2012	12/31/2023
1		8 in 1 BLISTER PACK; 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	03/19/2012	12/31/2023

Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

Revised: 10/2021

Document Id: 2c0e4942-17ab-47f2-a2d0-d1336b636f8b

Set id: a3b8b125-e058-482c-8a02-5bc5bd957447

Version: 5

Effective Time: 20211015