MECLIZINE - meclizine hcl tablet 
Contract Pharmacal Corp

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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Meclizine Chewables

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

Active ingredient

(in each tablet)

Meclizine HCl 25 mgi

Purpose

Antiemetic

Uses

for the prevention and treatment of the nausea, vomiting, dizziness associated with motion sickness

Warnings

Do not use

  • In children under 12 years of age unless directed by a doctor

Ask a doctor before use if you have

  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health care 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, the first dose should be taken one hour before starting activity.
  • Adults and children 12 years of age and over: chew 1 to 2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor.

DO NOT EXCEED RECOMMENDED DOSE

Other information

  • Store at room temperature, USP

Inactive ingredient

Corn Starch, Croscarmellose Sodium, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.

R02/11

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11a2b58b-figure-01
MECLIZINE 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 68401960MK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
RASPBERRY (UNII: 4N14V5R27W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
VANILLA (UNII: Q74T35078H)  
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize9mm
FlavorImprint Code 258
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-3206-1100 in 1 BOTTLE
2NDC:10267-3206-41000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33607/24/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 12/2011
Document Id: 11a2b58b-304c-4d79-920e-508701c3c19f
Set id: 6e297ed1-3734-4af3-b5ec-8fdc37dba808
Version: 1
Effective Time: 20111226
 
Contract Pharmacal Corp