MOTION SICKNESS RELIEF- meclizine hcl tablet
GREENBRIER INTERNATIONAL, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Assured 44-403

Active ingredient (in each tablet)

Meclizine HCl 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

glaucoma
difficulty in urination due to an enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

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 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.

Directions

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

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from heat and humidity
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gel

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT OF
DRAMAMINE® LESS DROWSY FORMULA*

Motion Sickness Relief
• Meclizine HCl Tablets, 25 mg / Antiemetic

Helps prevent Nausea and Dizziness due
to Motion Sickness for up to 24 hours

Actual Size

16 tablets

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.
50844 ORG071240321

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

ITEM# 229929
DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320

Assured 44-403

MOTION SICKNESS RELIEF
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-0403
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;403
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0403-1	2 in 1 CARTON	06/24/2002	07/08/2019
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	06/24/2002	07/08/2019

Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(33992-0403)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(33992-0403)

Revised: 7/2016

Document Id: 6739d9b1-adc1-43dc-af92-bc215d8aacbc

Set id: 8de24b61-5ff7-419f-bfc6-831d3f178887

Version: 2

Effective Time: 20160705

GREENBRIER INTERNATIONAL, INC.