CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Rugby Laboratories Inc

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Drug Facts

Active Ingredient (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 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 take 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 to 25°C (68 to 77°F)

Inactive Ingredients

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

Questions or comments?

Call 1-800-645-2158, 9am-5pm ET. Monday-Friday

Principal Display Panel

Compare to Active Ingredient in ZYRTEC®*

Original Prescription Strength

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

ANTIHISTAMINE

ALLERGY

Indoor and Outdoor Allergies

24 hour relief of:

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

*Rugby Laboratories is not affiliated with the owner of the trademark Zyrtec®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Label

Cetirizine 10 mg

Rugby Cetirizine 10 mg Allergy Tablet



CETIRIZINE HYDROCHLORIDE 
cetirizine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4088
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE (white) Score no score
Shape OVAL (oval) Size 8mm
Flavor Imprint Code IP;46
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-4088-11 4 in 1 BOX
1 90 in 1 BLISTER PACK
2 NDC:0536-4088-88 1 in 1 BOX
2 14 in 1 BLISTER PACK
3 NDC:0536-4088-07 2 in 1 BOX
3 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078780 03/23/2012
Labeler - Rugby Laboratories Inc (191427277)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
Document Id: 44912f39-94c7-455c-b756-0e874f4598b7
Set id: aec192f8-9e77-41f4-ad6a-e5e0cbcd5824
Version: 5
Effective Time: 20130422
 
Rugby Laboratories Inc