MECLIZINE 25- meclizine hydrochloride tablet 
The Generic Pharmaceutical Company

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 25

Drug Facts

Active Ingredients (in each immediate-release tablet)

Meclizine 25 mg

Purpose

Antiemetic

Indications and Usage

Warnings

Ask a doctor before use if you have

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

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

If pregnant or breast-feeding,

  • ask health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

Do not exceed recommended dosage.

To prevent motion sickness; take the first dose one hour before starting activity.

Adults and children 12 years of age and over:1 to 2 tablets once daily, or as directed by a doctor.

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions and comments?

Call 1-205-313-8298

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

NDC 57963-101-01
100 Tablets

Meclizine 25
Antiemetic

Each immediate-release tablet contains:
Meclizine HCl
25 mg

Store at 59°-86°F (15°-30°C)
[see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
MECLIZINE 25 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57963-101
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
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code MC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57963-101-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/01/2016
Labeler - The Generic Pharmaceutical Company (078787060)

Revised: 1/2017
Document Id: 6eafa4df-b743-4c70-9fe1-97c30b07d82d
Set id: b13cb390-20ed-43ce-aa74-5a754539f6e2
Version: 1
Effective Time: 20170109
 
The Generic Pharmaceutical Company