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Cetirizine Hydrochloride

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Avera McKennan Hospital
NDC Code: 69189-3635

Drug Facts

Active Ingredient (in each tablet)

Cetirizine hydrochloride USP, 5 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

1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.

adults 65 years and over

1 tablet once a day; do not take more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions?

Call 1-877-446-3679 (1-877-4-INFO-RX)

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

NDC 69189-3635-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69189-3635(NDC:0378-3635)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeM;C35
Contains    
Packaging
#Item CodePackage Description
1NDC:69189-3635-11 TABLET, FILM COATED in 1 DOSE PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667705/29/2015
Labeler - Avera McKennan Hospital (068647668)
Establishment
NameAddressID/FEIOperations
Avera McKennan Hospital068647668relabel(69189-3635), repack(69189-3635)

Revised: 11/2015
 
Avera McKennan Hospital

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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