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Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride (cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. Aurohealth LLC

Generic: cetirizine hydrochloride and pseudoephedrine hydrochloride is used for the treatment of Rhinitis, Allergic, Perennial Urticaria Asthma Common Cold Sinusitis

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride tablet, film coated, extended release - (cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release) image

IMPRINT: K15     SHAPE: round
    COLOR: yellow

  1. FDA Adverse Reactions

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Drug Facts


Active ingredients (in each extended release tablet) Cetirizine HCl USP 5 mg Pseudoephedrine HCl  USP 120 mg

Purpose


AntihistamineNasal 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

  • 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 carton is opened or if individual buler units are torn or broken

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)

Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India

Code: AP/DRUGS/04/2016

Package Label-principal Display Panel -5 Mg/120 Mg (12 X 2) Blister Carton


AUROHEALTH NDC 58602-703-09 *Compare to the active ingredients of Zyrtec-D® Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 5 mg/ 120 mg Antihistamine/Nasal Decongestant Allergy & Sinus INDOOR & OUTDOOR ALLERGIES 12 HOUR RELIEF NASAL CONGESTION & SINUS  PRESSURE
  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy  Nose or Throat

(Actual Size)  

24 EXTENDED-RELEASE TABLETS

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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