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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  •  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 overtake 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Active Ingredient in ZYRTEC®*

Original Prescription Strength

ALLERGY RELIEF

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

ANTIHISTAMINE

ALLERGY

Indoor and Outdoor Allergies

24 hour relief of:

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itchy throat or nose

TABLETS

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING   

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

Distributed by:

Rugby Laboratories

17177 N Laurel Park Dr., Suite 233

Livonia, MI  48152

www.rugbylaboratories.com

Product Label

Cetirizine HCI 10 mg

RUGBY Allergy Relief



CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4088
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (white) Scoreno score
ShapeOVAL (oval) Size8mm
FlavorImprint Code IP;46
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-4088-881 in 1 BOX03/23/201202/28/2020
114 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0536-4088-072 in 1 BOX03/23/201202/28/2020
230 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0536-4088-111 in 1 BOX03/23/201202/28/2020
390 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07878003/23/201202/28/2020
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 1/2019
Document Id: a78dc390-30b6-4362-a088-022d76121e83
Set id: aec192f8-9e77-41f4-ad6a-e5e0cbcd5824
Version: 10
Effective Time: 20190107
 
Rugby Laboratories, Inc.