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Zentrip

Dosage form: film, soluble
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-803

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.

DRUG FACTS BOX

Active ingredient (in each strip)    
Meclizine hydrochloride 25mg

Purpose  
Meclizine hydrochloride    Antiemetic

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

Warnings

Enter section text here

Do not use in children under 12 years of age unless directed by a physician

Ask a doctor before use if you have
■ glaucoma   ■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland

Ask a physician or pharmacist before use if you are
■ taking sedatives or tranquilizers

When using this product
■ you may get drowsy   ■ avoid alcoholic beverages
■ be careful when driving a motor vehicle or operating machinery
■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect

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 it at least one hour before traveling    
Adults and children 12 years of age and over:  Oral dosage is 1 to 2 strips (25 to 50 mg) to dissolve on tongue once daily, or as directed by a physician.

Other information 
■ Store tightly closed, protected from light, at 20-30°C. (68-86°F)

Inactive ingredients
acesulfame potassium, , ferric oxide, hypromelloses, mannitol, menthol, orange oil, polyethylene glycol 400, sucralose, sucrose esters of fatty acids

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ZENTRIP 
meclizine hydrochloride film, soluble
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-803
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
MANNITOL 
LEVOMENTHOL 
ORANGE OIL 
SUCRALOSE 
SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:49873-803-018 PACKET (PACKET) in 1 CARTON
11 FILM, SOLUBLE (FILM) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/03/2009
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Revised: 07/2012
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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