MECLINZINE HYDORCHLORIDE- meclinzine hydrochloride - chewable tablet, chewable

meclinzine hydorchloride by

Drug Labeling and Warnings

meclinzine hydorchloride by is a Otc medication manufactured, distributed, or labeled by Bellegrove Medical Supply, Inc., Future Pak, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Do not use
for children under 12 years of age unless unless directed by a physician
for frequent or prolonged use except under the advice of a physician

Ask a doctor before use if you have

breathing problems such as emphysema, asthma or pulmonary disease
glaucoma

if you are 

• taking sedatives or tranquilizers

When using this product

drowsiness may occur
alcohol, sedatives and tranquilizers may increase the drowsiness effect
consult with your physician
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage

If preganant or breast-feeding, ask a health professional before use

Keep out of reach of children.  In case of overdose, get medical help or contact Poison Control Center right away

Other information

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

DOSAGE AND ADMINISTAATION

Directions

do not use more than directed
to provent 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 Physician

Do not exceed 2 tablets in 24 hours

Children under 12 years of age: Do not give to children under 12 years of age

INDICATION AND USAGE

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

OTC-KEEP OUT OF REACH OF CHILDREN

Do not use
for children under 12 years of age unless unless directed by a physician
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away

PURPOSE

When using this product

drowsiness may occur
alcohol, sedatives and tranquilizers may increase the drowsiness effect
consult with your physician
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery

Active ingredients

anhydrous lactose

Inactive ingredients

Anhydrous Lactose, Colloidal Silicon Dioxide, Crospovidone, Dextrose, FD&C red #40 aluminum lake, magnesium stearate, Microcrystalline Cellulose, Modified Corn Starch, Propylene Glycol, Raspberry Flavor, Silicon Dioxide, Sodium Saccharin, Stearic Acid, Talc and Vanilla Flavor.

Package label

INGREDIENTS AND APPEARANCE

MECLINZINE HYDORCHLORIDE 
meclinzine hydrochloride - chewable tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59961-125
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Meclizine hydrochloride (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	Meclizine hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous lactose (UNII: 3SY5LH9PMK)	1 mg

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	10mm
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59961-125-01	2 in 1 PACKAGE	01/01/2012
1	NDC: 59961-125-02	500 in 1 BOX; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	01/01/2012

Labeler - Bellegrove Medical Supply, Inc. (141647094)

Registrant - Bellegrove Medical Supply, Inc. (141647094)

Establishment
Name	Address	ID/FEI	Business Operations
Future Pak, Ltd.		087737672	api manufacture(59961-125) , pack(59961-125) , relabel(59961-125)