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Cetirizine Hydrochloride by Proficient Rx LP

Dosage form: tablet, film coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Proficient Rx LP
NDC Code: 63187-932

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
1.
drowsiness may occur
2.
avoid alcoholic drinks
3.
alcohol, sedatives, and tranquilizers may increase drowsiness
4.
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° - 77°F)
USP Dissolution Test 3

Inactive ingredients

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

Questions or comments?

call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Manufactured by:

Manufactured for:

Repackaged by:

Apotex Inc.

Apotex Corp.

Proficient Rx LP

Toronto, Ontario

Weston, Florida

Thousand Oaks, CA 91320

Canada M9L 1T9

33326

PRINCIPAL DISPLAY PANEL - 10 mg

APOTEX CORP. NDC 63187-932-30

Cetirizine 10 mg

Cetirizine Hydrochloride Tablets

Antihistamine/Original Prescription Strength 

Indoor & Outdoor Allergies

24 hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

30 count

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-932(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 
MICROCRYSTALLINE CELLULOSE 
STARCH, CORN 
MAGNESIUM STEARATE 
HYPROMELLOSE, UNSPECIFIED 
POLYDEXTROSE 
POLYETHYLENE GLYCOL 3350 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLE (pillow-shaped) Size9mm
FlavorImprint Code10MG;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-932-1515 TABLET, FILM COATED in 1 BOTTLE
2NDC:63187-932-3030 TABLET, FILM COATED in 1 BOTTLE
3NDC:63187-932-6060 TABLET, FILM COATED in 1 BOTTLE
4NDC:63187-932-9090 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07831712/27/2007
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-932), RELABEL(63187-932)

 
Proficient Rx LP

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Medically reviewed on Dec 1, 2017

Further information

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

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