MECLIZINE HCL- meclizine hydrochloride chewable tablets tablet, chewable 
Trigen Laboratories, 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

Active Ingredients (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses:

prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.

WARNING: Ask a doctor before use if you have

• Glaucoma • A breathing problem such as emphysema or chronic bronchitis • Trouble urinating due to an enlarged prostate gland.

KEEP OUT OF REACH OF CHILDREN

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

When using product

• You may get drowsy • 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 a Physician 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 dose one hour before travel starts • Tablets can be chewed or swallowed whole with water • Adults & children 12 years and over: 1-2 tablets once daily • Children under 12 years: ask a doctor

Other Information

• each tablet contains: calcium 51 mg

• Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Microcrystalline cellulose, magnesium stearate, lactose, Raspberry flavor, FD&C Red #40 lake, starch, sodium saccharin, and dextrates hydrated.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

TRIGEN
LABORATORIES

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 08/13

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

NDC 13811-648-10

Meclizine HCl
25 mg

100 CHEWABLE TABLETS

TRIGEN
LABORATORIES

PRINCIPAL DISPLAY PANEL - 25 mg - 100 chewable tablets
MECLIZINE HCL 
meclizine hydrochloride chewable tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-648(NDC:57631-009)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE (UNII: J2B2A4N98G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
DEXTRATES (UNII: G263MI44RU)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code ET1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13811-648-10100 in 1 BOTTLE
2NDC:13811-648-011000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33609/23/2013
Labeler - Trigen Laboratories, Inc. (830479668)
Registrant - Trigen Laboratories, Inc.. (830479668)

Revised: 9/2013
Document Id: 79a4bd44-386d-4756-b772-d60c0c3be05c
Set id: ccab7b75-29c0-4024-a4a0-e506732e56ab
Version: 1
Effective Time: 20130915
 
Trigen Laboratories, Inc.