Cetirizine and Pseudoephedrine

Dosage Form: tablet, film coated, extended release
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

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

mg/120 mg Blister Pack

Cetirizine HCl and

Pseudoephedrine

HCl Extended

Release Tablet

5 mg/120 mg

Sandoz Inc., Princeton, NJ 08540

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  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

More Cetirizine and Pseudoephedrine resources

• Cetirizine and Pseudoephedrine Side Effects (in more detail)
• Cetirizine and Pseudoephedrine Dosage
• Cetirizine and Pseudoephedrine Use in Pregnancy & Breastfeeding
• Cetirizine and Pseudoephedrine Drug Interactions
• Cetirizine and Pseudoephedrine Support Group
• 3 Reviews for Cetirizine and Pseudoephedrine - Add your own review/rating

Compare Cetirizine and Pseudoephedrine with other medications

• Hay Fever