Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

DRUG FACTS

(in each extended-release tablet)

Cetirizine HCl USP 5 mg

Pseudoephedrine HCl USP 120 mg

Antihistamine

Nasal decongestant

• 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

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
• In rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

Stop use and ask 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

• 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

• store between 20° to 25°C (68° to 77°F)
• do not use if blister unit is torn or broken
• keep the carton.  It contains important information.

colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

call 1-866-562-4616 from Monday to Friday between 8.00 AM to 8.00 PM, EST

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez,

Goa 403511, India.

Manufactured for:

12 count-

13013737

03-R-08/2026

24 count-

13013738

03-R-08/2026

[Image in the official label — see DailyMed source]

East Brunswick, NJ 08816.

[Image in the official label — see DailyMed source]