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Cetirizine Hydrochloride by American Health Packaging

Medically reviewed on July 31, 2017

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: American Health Packaging
NDC Code: 60687-165

Cetrizine HCL Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

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

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

if breast-feeding; not recommended
if pregnant; 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

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information
store between 20° and 25°C (68° and 77°F)
FOR YOUR PROTECTION: Do not use product if blister is torn or broken
USP Dissolution Test 3

Inactive ingredients

Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.

Questions or comments?

about the drug call Apotex Corporation at 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time; about the packaging call American Health Packaging at 1-800-707-4621

PRINCIPAL DISPLAY PANEL

NDC 60687-165-01

Cetirizine
Cetirizine Hyrdrochloride Tablets, USP
Antihistamine
Indoor and Outdoor Allergies

10 mg
24 Hour

100 Tablets (10 x 10)

The drug product contained in this
package is from NDC # 60505-2633,
Apotex Corp.

Packaged and Distributed by:
American Health Packaging,
2550 John Glenn Avenue, Suite A,
Columbus, OH 43217

716501
Rev. 05/2015

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-165(NDC:60505-2633)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
MAGNESIUM STEARATE 
HYPROMELLOSES 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 3350 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:60687-165-01100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:60687-165-111 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831707/20/2015
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIOperations
American Health Packaging929561009REPACK(60687-165)

 
American Health Packaging

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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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