MEDIQUE MEDI-MECLIZINE- meclizine hydrochloride tablet, film coated
Unifirst First Aid Corporation

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.

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Drug Facts

Active ingredient (in each tablet)

Meclizine Hydrochloride 25mg

Purpose

Antiemetic

Uses

For the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Warnings

Do not use

for children under 12 years of age unless directed by a doctor
for frequent or prolonged use except under the advice of a doctor

Ask a doctor before use

if you have

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

if you are

taking sedatives or tranquilizers

When using this product

drowsiness may occur
avoid alcoholic beverages. Alcohol, sedatives and tranquilizers may increase the drowsiness effect.
use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

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

do not use more than directed
to prevent motion sickness, take the first dose one hour before starting activity

Adults and children:
(12 years and older)

1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

store at room temperature 15-30°C (59- 86° F)
tamper-evident sealed packets
do not use any opened or torn packets

Inactive ingredients

Corn starch, croscarmellose sodium, D&C yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, silica, stearic acid.

Questions or comments Call 1-800-634-7680

Principal Display Panel - 479R Medique Medi-Meclizine Label

Medique®

Medi-Meclizine

Meclizine Hydrochloride

For the Prevention and Treatment of Motion Sickness

Para la Prevencion y el Tratamiento del Mareo “Mal del Viajero”

Pull to Open

Tire Para Abrir

All Day Relief

Alivio que Perdura Todo el Dia

Easy To Swallow

Film Coated Tablets

Facil de Tragar Tabletas con Cubierta Pelicular

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

Principal Display Panel - 479R Medique Medi-Meclizine Label

MEDIQUE MEDI-MECLIZINE
meclizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-479
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (MECLIZINE)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID

Product Characteristics
Color	yellow (yellow)	Score	no score
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	CPC;2691
Contains

Packaging
#	Item Code	Package Description
1	NDC:47682-479-33	50 in 1 BOX, UNIT-DOSE
1	NDC:47682-479-99	2 in 1 PACKET
2	NDC:47682-479-15	500 in 1 BOX, UNIT-DOSE
2	NDC:47682-479-99	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	12/30/2008

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 09/2010

Document Id: 7e0a68c3-8c13-46be-918c-55fcf55d37aa

Set id: 77ca0ee1-cb46-44a9-911f-5adbede9b01a

Version: 1

Effective Time: 20100920

Unifirst First Aid Corporation