ZENTRIP- meclizine hydrochloride film, soluble
Sato Pharmaceutical Co., Ltd.

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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Zentrip Strips De-listing

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

carton

ZENTRIP
meclizine hydrochloride film, soluble

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49873-803
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49873-803-01	8 in 1 CARTON	02/03/2009	01/06/2021
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	02/03/2009	01/06/2021

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

Revised: 7/2022

Document Id: e3525c70-6ec5-420d-e053-2a95a90a75c5

Set id: bcd069ef-8f16-4dbb-8829-0f152d42687d

Version: 4

Effective Time: 20220708

Sato Pharmaceutical Co., Ltd.