CETIRIZINE HYDROCHLORIDE   - cetirizine hydrochloride tablet 
Rugby Laboratories, Inc.

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Active Ingredients

(in each tablet)

Cetirizine HCl 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 drink

● 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

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 6years andoverOne 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 65years andoverask a doctor.
Children under 4-6 years of ageask a doctor
Children under 4 years of age
ask a doctor
Consumers with liver or kidney diseaseask a doctor

Other Information

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

Inactive Ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

Questions or comments?

Call 1-800-645-2158

9am-5pm ET. Monday-Friday


Rugby Laboratories, Inc is not affiliated with the owner of the trademark Zyrtec. Rugby Cetirizine Hydrochloride Tablets 10mg are distributed by Rubgy Laboratories, Inc.

Rugby
Duluth, Georgia 30097

Package Labeling

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CETIRIZINE HYDROCHLORIDE  
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4088
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white) Score no score
ShapeOVAL (oval) Size8mm
FlavorImprint Code IP;46
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0536-4088-881 BLISTER PACK ( BLISTER PACK) in 1 BOXcontains a BLISTER PACK
114 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the BOX (0536-4088-88)
2NDC:0536-4088-072 BLISTER PACK ( BLISTER PACK) in 1 BOXcontains a BLISTER PACK
230 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the BOX (0536-4088-07)
3NDC:0536-4088-114 BLISTER PACK ( BLISTER PACK) in 1 BOXcontains a BLISTER PACK
390 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the BOX (0536-4088-11)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07878003/23/2012

Labeler - Rugby Laboratories, Inc. (109178264)

Revised: 03/2012 Rugby Laboratories, Inc.