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Meclizine HCl by Trigen Laboratories, Inc.

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 12.5 mg
Labeler: Trigen Laboratories, Inc.
NDC Code: 13811-646

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 Ingredients (in each caplet)

Meclizine HCl 12.5 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

• Adults & children 12 years and over: 2-4 caplets once daily

• Children under 12 years: ask a doctor

Other Information

• each caplet contains: calcium 51 mg

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

Inactive ingredients

Microcrystalline cellulose, magnesium stearate, sodium starch glycolate, crospovidone, talc, and lactose.

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 - 12.5 mg Caplet Label

NDC 13811-646-10

Meclizine HCl
12.5 mg

100 CAPLETS

TRIGEN
LABORATORIES

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

MECLIZINE HCL 
meclizine hydrochloride tablets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-646(NDC:57631-007)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE12.5  mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
POVIDONE K30 
TALC 
LACTOSE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint CodeET5
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-646-10100 TABLET (TABLET) in 1 BOTTLE
2NDC:13811-646-011000 TABLET (TABLET) 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)

 
Trigen Laboratories, Inc.

← See all Meclizine HCl brands

Medically reviewed on Sep 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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