CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL ER- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release 
Sandoz Inc

----------

Active Ingredient (in each extended release tablet)

Cetirizine HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
∘
runny nose
∘
itchy, watery eyes
∘
nasal congestion
∘
sneezing
∘
itching of the nose or throat
•
reduces swelling of nasal passages
•
temporarily relieves sinus congestion and pressure
•
temporarily restores freer breathing through the nose

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.
•
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

•
heart disease
•
thyroid disease
•
diabetes
•
glaucoma
•
high blood pressure
•
trouble urinating due to an enlarged prostate gland
•
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

•
do not use more than directed
•
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.
•
you get nervous, dizzy, or sleepless
•
symptoms do not improve within 7 days or are accompanied by fever

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

•
do not break or chew tablet; swallow tablet whole

adults and children 12 years and over

take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.

adults 65 years and over

ask a doctor

children under 12 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other Information

•
Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
•
DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only).

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.

Questions or comments?

1-800-525-8747

Sandoz Inc.

Princeton, NJ 08540

05-2010M

5 mg/120 mg Label

NDC 0781-5285-31

Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/

nasal decongestant

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 hour Relief of

Runny Nose Itchy, Watery Eyes Sinus Pressure

Sneezing Itchy Throat or Nose Nasal Congestion

SANDOZ

30 Tablets

Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Label

5 mg/120 mg Blister Pack

Cetirizine HCl and

Pseudoephedrine

HCl Extended

Release Tablet

5 mg/120 mg

Sandoz Inc., Princeton, NJ 08540

Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Blister Pack

5 mg/120 mg Blister Pack Carton

NDC 0781-5285-40

Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/nasal decongestant

24 Tablets (4 x 6)

SANDOZ

ALLERGY &

CONGESTION

12 hour Relief of

Runny Nose

Itchy, Watery Eyes

Sinus Pressure

Sneezing

Itchy Throat or Nose

Nasal Congestion

Indoor &

Outdoor

Allergies

Cetirizine HCl and Pseudoephedrine HCl 5 mg and 120 mg Blister Pack Carton
CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL  ER
cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0781-5285
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
HYPROMELLOSE 2208 (15000 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONE 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize10mm
FlavorImprint Code SZ912
Contains    
Packaging
#Item CodePackage Description
1NDC:0781-5285-404 in 1 CARTON
1NDC:0781-5285-066 in 1 BLISTER PACK
2NDC:0781-5285-3130 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07799103/05/200810/01/2012
Labeler - Sandoz Inc (110342024)

Revised: 05/2013
Document Id: c2884422-8984-41bc-8433-1e15e4252a28
Set id: 4965ed02-203d-4514-9df9-ddedd19acc55
Version: 13
Effective Time: 20130522
 
Sandoz Inc