ANTIVERT - meclizine hydrochloride tablet 
Roerig

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ANTIVERT®
Tablets/12.5 mg meclizine HCl
 
ANTIVERT®/25
Tablets/25 mg meclizine HCl
 
ANTIVERT®/50
Tablets/50 mg meclizine HCl

DESCRIPTION

Chemically, Antivert® (meclizine HCl) is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

Chemical Structure

Inert ingredients for the tablets are: dibasic calcium phosphate; magnesium stearate; polyethylene glycol; starch; sucrose. The 12.5 mg tablets also contain: Blue 1. The 25 mg tablets also contain: Yellow 6 Lake; Yellow 10 Lake. The 50 mg tablets also contain: Blue 1 Lake; Yellow 10 Lake.

ACTIONS

Antivert is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

INDICATIONS

Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows:

Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.

Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system.

Final classification of the less than effective indications requires further investigation.

CONTRAINDICATIONS

Meclizine HCl is contraindicated in individuals who have shown a previous hypersensitivity to it.

WARNINGS

Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

Patients should avoid alcoholic beverages while taking this drug.

Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

Usage in Children

Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.

Usage in Pregnancy

Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25–50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.

ADVERSE REACTIONS

Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

DOSAGE AND ADMINISTRATION

Vertigo

For the control of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

Motion Sickness

The initial dose of 25 to 50 mg of Antivert should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

HOW SUPPLIED

Antivert®—12.5 mg tablets:
  Bottles of 100
    (NDC 0662-2100-66),
    (NDC 0049-2100-66)
  Bottles of 1000
    (NDC 0662-2100-82),
    (NDC 0049-2100-82)

Antivert®/25—25 mg tablets:
  Bottles of 100
    (NDC 0662-2110-66),
    (NDC 0049-2110-66)
  Bottles of 1000
    (NDC 0662-2110-82),
    (NDC 0049-2110-82)

Antivert®/50—50 mg tablets:
  Bottles of 100
    (NDC 0662-2140-66),
    (NDC 0049-2140-66)

Logo

LAB-0142-2.0

October 2006

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

NDC 0049-2100-66

100 Tablets

Antivert®
(meclizine HCl)

12.5 mg

Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Label

NDC 0049-2110-66

100 Tablets

Antivert®
(meclizine HCl)

25 mg

Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Label

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Label

NDC 0049-2140-66

100 Tablets

Antivert®
(meclizine HCl)

50 mg

Pfizer
Distributed by
Roerig
Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Label

ANTIVERT 
meclizine hydrochloride   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-2100
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
meclizine hydrochloride (meclizine) meclizine hydrochloride 12.5 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous dibasic calcium phosphate  
magnesium stearate  
polyethylene glycol  
sucrose  
FD&C Blue No. 1  
Product Characteristics
Color BLUE, WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code Antivert;210
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0049-2100-66 100 TABLET In 1 BOTTLE None
2 0049-2100-82 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA010721 04/11/1997

ANTIVERT 
meclizine hydrochloride   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-2110
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
anhydrous dibasic calcium phosphate  
magnesium stearate  
polyethylene glycol  
sucrose  
FD&C Yellow No. 6  
D&C Yellow No. 10  
Aluminum Oxide  
Product Characteristics
Color YELLOW, WHITE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code Antivert;211
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0049-2110-66 100 TABLET In 1 BOTTLE None
2 0049-2110-82 1000 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA010721 04/11/1997

ANTIVERT 
meclizine hydrochloride   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-2140
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
meclizine hydrochloride (meclizine) meclizine hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous dibasic calcium phosphate  
magnesium stearate  
polyethylene glycol  
sucrose  
FD&C Blue No. 1  
D&C Yellow No. 10  
Aluminum Oxide  
Product Characteristics
Color YELLOW, BLUE Score 2 pieces
Shape OVAL Size 16mm
Flavor Imprint Code Antivert;214
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0049-2140-66 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA010721 04/11/1997

Labeler - Roerig (829076996)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084545 API MANUFACTURE, MANUFACTURE
Establishment
Name Address ID/FEI Operations
DR. REDDY'S LABORATORIES LIMITED (Mexico site) 812915445 API MANUFACTURE
Revised: 01/2010 Roerig