ZENTRIP- meclizine hydrochloride film, soluble

Zentrip by

Drug Labeling and Warnings

Zentrip by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each strip)    
Meclizine hydrochloride 25mg

PURPOSE

Purpose  
Meclizine hydrochloride    Antiemetic

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZENTRIP 
meclizine hydrochloride film, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-803
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MANNITOL (UNII: 3OWL53L36A)
LEVOMENTHOL (UNII: BZ1R15MTK7)
ORANGE OIL (UNII: AKN3KSD11B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) (UNII: L98X941W2B)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-803-01	8 in 1 CARTON	02/03/2009
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	02/03/2009

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)