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
5 mg/120 mg Blister Pack
Cetirizine HCl and
Pseudoephedrine
HCl Extended
Release Tablet
5 mg/120 mg
Sandoz Inc., Princeton, NJ 08540
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