CVS MOTION SICKNESS FAST MELTING- meclizine hydrochloride tablet, orally disintegrating 
CVS Pharmacy, 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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DRUG FACTS BOX

Active ingredient (in each tablet) 
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:  take 1 to 2 (25 to 50 mg) tablets once daily, or as directed by a physician.

Other information
■ Store at 20-30°C (68-86°F)

Inactive ingredients
acesulfame potassium, erythritol, hydroxypropyl cellulose, colloidal silicon dioxide, mannitol, menthol, sodium stearyl fumarate, yellow ferric oxide.

Carton

PDP

CVS MOTION SICKNESS FAST MELTING 
meclizine hydrochloride tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-534
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
ERYTHRITOL (UNII: RA96B954X6)  
MANNITOL (UNII: 3OWL53L36A)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
Product Characteristics
Color yellow Score no score
Shape ROUND Size 13mm
Flavor Imprint Code SJ
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-534-01 1 in 1 CARTON
1 12 in 1 BLISTER PACK; 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 08/27/2015
Labeler - CVS Pharmacy, Inc. (062312574)

Revised: 8/2015
Document Id: f1e8fab8-7a37-45a6-a944-82b83c93551e
Set id: 2a723bce-a581-4558-b028-22f1f9125dd5
Version: 1
Effective Time: 20150827
 
CVS Pharmacy, Inc.