Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
FDA Label NDC 63868-964

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 63868-964). 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 active ingredients, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients


Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 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

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) (cer tain 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.

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 inner safety seal is open or torn
  • 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

Principal Display Panel - Showbox


NDC 63868-964-24
*Compare to the active Ingredient in ZYRTEC-D®
Original Prescription Strength
Allergy Relief-D
Cetirizine HCl and Pseudoephedrine HCl Extended-release Tablets, USP
5 mg/120 mg

Indoor & Outdoor Allergies

ALLERGY & CONGESTION
12 Hour Relief of:
Sneezing
Itchy, Watery Eyes
Runny Nose
Sinus Pressure 
Itching Throat or nose
Nasal Congestion

DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
24 Tablets (4 blister cards of 6 tablets each)
QUALITY CHOICE

Spl-cetrizine-psedoephedrine (Spl Cetrizine Psedoephedrine)

Spl-cetrizine-psedoephedrine (Spl Cetrizine Psedoephedrine)

* Please review the disclaimer below.