CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Apotheca Inc.

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Cetirizine 10mg Tablets, Allergy Tablets DRUG FACTS

ACTIVE INGREDIENT

(in each Tablet)
Cetirizine HCI 10mg

PURPOSE

ANTIHISTAMINE
24 Hour Relief of Indoor and Outdoor Allergies

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

Stop use and ask a doctor

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact 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.
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 and inactive ingredients

Other information Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL

NDC 12634-987-71
CETIRIZINE HCI
Antihistamine
Indoor and Outdoor Allergies

24 Hour Relief of Sneezing, Runny Nose, Itchy,
Watery Eyes, Itchy Throat or Nose.
Allergy Tablets
RejuviLife
30 Tablets
10 MG
image of label

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-987(NDC:0378-3637)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (WHITE) Scoreno score
ShapeBULLET (Barrel Shaped) Size8mm
FlavorImprint Code M;C37
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12634-987-966 in 1 BOTTLE, PLASTIC
2NDC:12634-987-977 in 1 BOTTLE, PLASTIC
3NDC:12634-987-0010 in 1 BOTTLE, PLASTIC
4NDC:12634-987-8020 in 1 BOTTLE, PLASTIC
5NDC:12634-987-7130 in 1 BOTTLE, PLASTIC
6NDC:12634-987-5050 in 1 BOTTLE, PLASTIC
7NDC:12634-987-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07667701/01/2010
Labeler - Apotheca Inc. (051457844)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Inc.051457844repack, relabel

Revised: 4/2010
Document Id: 4ff5ce14-77ce-4757-a40e-e7099f15a011
Set id: abaf61ad-17bd-4dcf-aff1-6687c4cb1b9f
Version: 2
Effective Time: 20100407
 
Apotheca Inc.