Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
| Cetirizine HCl, USP 5 mg | Antihistamine |
| Pseudoephedrine HCl, USP 120 mg | Nasal Decongestant |
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of nose or throatnasal congestion
- 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.
OTC - ASK DOCTOR/PHARMACIST SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened or if the blister unit is broken
- see side panel for batch number and expiration date
Inactive ingredients
hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide
Imprinting Ink Contents
ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze
Questions?
call toll free 1-800-818-4555 weekdays
SPL UNCLASSIFIED SECTION
Manufactured by:Sun Pharmaceutical Industries LimitedSurvey No. 1012, Dadra-396 193,U.T. of D & NH and Daman & Diu, India.
Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901