MECLINZINE HYDORCHLORIDE- meclinzine hydrochloride - chewable tablet, chewable 
Bellegrove Medical Supply, 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.

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Meclizine Hydrochloride - Chewable

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 

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

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

Package label

MECLINZINE HYDORCHLORIDE 
meclinzine hydrochloride - chewable tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59961-125
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Meclizine hydrochloride (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) Meclizine hydrochloride25 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous lactose (UNII: 3SY5LH9PMK) 1 mg
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize10mm
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59961-125-012 in 1 PACKAGE01/01/2012
1NDC:59961-125-02500 in 1 BOX; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/01/2012
Labeler - Bellegrove Medical Supply, Inc. (141647094)
Registrant - Bellegrove Medical Supply, Inc. (141647094)
Establishment
NameAddressID/FEIBusiness Operations
Future Pak, Ltd.087737672api manufacture(59961-125) , pack(59961-125) , relabel(59961-125)

Revised: 11/2020
Document Id: 1109f809-f48b-4e0d-80a3-d786a6fd5723
Set id: 9b50cae4-e10d-40d1-bad2-d8b53aee74fd
Version: 5
Effective Time: 20201102
 
Bellegrove Medical Supply, Inc.