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Rugby Laboratories Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets Drug Facts


Active ingredients (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
  • •sneezing
  • •itchy, watery eyes
  • •itching of the nose or throat
  • •nasal 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.

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. (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 blister unit is broken or torn
  • •see side panel for lot number and expiration date
  • •meets USP Dissolution Test 2

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide