OTC Medication Information: Zentrip

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.

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

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

ZENTRIP meclizine hydrochloride film, soluble

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM HYPROMELLOSES POLYETHYLENE GLYCOL 400 MANNITOL LEVOMENTHOL ORANGE OIL SUCRALOSE SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) FERRIC OXIDE YELLOW

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49873-803-01 8 PACKET in 1 CARTON contains a PACKET 1 1 FILM, SOLUBLE in 1 PACKET This package is contained within the CARTON (49873-803-01)

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)

Revised: 01/2021 Sato Pharmaceutical Co., Ltd.