Meclizine Hydrochloride

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 12.5mg
Labeler: Sandoz Inc
NDC Code: 0781-1345

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.

Drug Facts

Active ingredient

Meclizine hydrochloride, USP 12.5 mg

Meclizine hydrochloride, USP 25 mg

Purpose

Antiemetic

Uses

For prevention and treatment of these symptoms associated with motion sickness

  • nausea
  • vomiting
  • dizziness

Warnings

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are
  • giving this product to children under 12 years of age
  • taking sedatives or tranquilizers

When using this product
  • you may get drowsy
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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
  • take first dose one hour before starting activity
  • adults and children (12 years and over) 25 to 50 mg (2 to 4 tablets) once daily or as directed by a doctor
  • not more than 4 tablets in 24 hours

Other Information
  • Safety sealed: do not use if the imprinted bottle seal is open or torn.
  • Keep tightly closed

  • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive ingredients

Croscarmellose sodium, FD&C blue #1 aluminum lake, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose and polysorbate 80

Questions or comments?

1-800-525-8747

Sandoz Inc.

Princeton, NJ 08540

10-2008M

12.5 mg Label

NDC 0781-1345-01

Meclizine HCl

Tablets, USP

12.5 mg

Antiemetic

Relief of:

Nausea Vomiting Dizziness

100 Tablets

SANDOZ

25 mg Label

NDC 0781-1375-01

Meclizine HCl

Tablets, USP

25 mg

Antiemetic

Relief of:

Nausea Vomiting Dizziness

100 Tablets

SANDOZ

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0781-1345
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScorescore with uneven pieces
ShapeOVALSize5mm
FlavorImprint CodeGG;141
Contains    
Packaging
#Item CodePackage Description
1NDC:0781-1345-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33605/22/1989
MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0781-1375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
Product Characteristics
ColorYELLOWScorescore with uneven pieces
ShapeOVALSize6mm
FlavorImprint CodeGG;261
Contains    
Packaging
#Item CodePackage Description
1NDC:0781-1375-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33605/22/1989
Labeler - Sandoz Inc (110342024)

Revised: 04/2012
 
Sandoz Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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