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 noseitchy, watery eyesnasal congestionsneezingitching 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
| 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 |
- do not break or chew tablet; swallow tablet whole
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).
STORAGE AND HANDLING SECTION
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.
SPL UNCLASSIFIED SECTION
Sandoz Inc.
Princeton, NJ 08540
05-2010M
Relabeling of Additional Barcode by:Physicians Total Care, Inc.Tulsa, OK 74146
HOW SUPPLIED SECTION
HOW SUPPLIED:
30 Tablets, Bottles NDC 54868-5884-1
60 Tablets, Bottles NDC 54868-5884-0
24 Tablets, Blister Pack NDC 54868-5884-2
5 mg/120 mg Label
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