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

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Drug Facts

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

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 Type	HUMAN OTC DRUG	NDC Product Code (Source)	0781-5285
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE)	CETIRIZINE HYDROCHLORIDE	5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2208 (15000 CPS)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	SZ912
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0781-5285-40	4 BLISTER PACK In 1 CARTON	contains a BLISTER PACK (0781-5285-06)
1	0781-5285-06	6 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (0781-5285-40)
2	0781-5285-31	30 TABLET In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077991	03/05/2008

Labeler - Sandoz Inc (110342024)

Establishment
Name	Address	ID/FEI	Operations
Sandoz Inc		110342024	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Thermo-Pak, Inc		161049044	PACK, LABEL

Revised: 06/2010Sandoz Inc