CETIRIZINE HYDROCHLORIDE - Unichem Pharmaceuticals (USA), Inc.

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Cetirizine HCl USP 5 mg

Pseudoephedrine HCl USP 120 mg

SPL UNCLASSIFIED SECTION

Antihistamine

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY INFORMATION

• 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

East Brunswick, NJ 08816.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

• Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• PSEUDOEPHEDRINE HYDROCHLORIDE
• PSEUDOEPHEDRINE
• CELLULOSE, MICROCRYSTALLINE
• CROSCARMELLOSE SODIUM
• FERRIC OXIDE YELLOW
• HYPROMELLOSE 2208 (100000 MPA.S)
• HYPROMELLOSE 2208 (4000 MPA.S)
• HYPROMELLOSE 2910 (5 MPA.S)
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POLYETHYLENE GLYCOL 400
• SILICON DIOXIDE
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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Reported adverse events (FAERS/openFDA)#

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