Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
FDA Label NDC 29300-313

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unichem Pharmaceuticals (usa), Inc. for the product Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 29300-313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

Antihistamine

Nasal decongestant

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:

Unichem Logo (4b7306be 266a 4245 Becc 749cf24b1210 01)

Unichem Logo (4b7306be 266a 4245 Becc 749cf24b1210 01)

East Brunswick, NJ 08816.

Active Ingredients

(in each extended-release tablet)

Cetirizine HCl USP 5 mg

Pseudoephedrine HCl USP 120 mg

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

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.

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 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

  • 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

  • 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.

* Please review the disclaimer below.