CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, film coated 
McKesson

----------

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 reation 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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20° to 25°C (68° to 77°F).

Inactive ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white.

The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide.

Questions ?

call 1-866-562-4590

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton: 30 Tablets

Sunmark

COMPARE TO ZYRTEC®

ACTIVE INGREDIENT*

NDC 49348-939-44

24 hour

all day allergy

Cetirizine HCl Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour relief of: sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

Original Prescription Strength

ALLERGY

30 TABLETS 10 mg EACH

carton30
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-939
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
POVIDONE K29/32 
MAGNESIUM STEARATE 
HYPROMELLOSE 2910 (5 MPA.S) 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeCAPSULE (Rounded-off;Rectangular) Size9mm
FlavorImprint Code S;521
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-939-441 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
2NDC:49348-939-121 in 1 CARTON
260 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07886208/01/2011
Labeler - McKesson (177667227)

Revised: 07/2011
Document Id: d96a89af-fbfd-4e88-9f57-1abac84e95a9
Set id: 029640e5-aaa0-4748-8c2a-b7aaff40d894
Version: 3
Effective Time: 20110701
 
McKesson