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Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride (fexofenadine hydrochloride 60 mg pseudoephedrine hydrochloride 120 mg) Dailymed

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

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

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride tablet, film coated, extended release - (fexofenadine hydrochloride 60 mg pseudoephedrine hydrochloride 120 mg) image

IMPRINT: Z 79     SHAPE: oval
    COLOR: yellow

  1. FDA Adverse Reactions

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Drug Facts


Active ingredients (in each tablet) Fexofenadine HCl USP 60 mgPseudoephedrine 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
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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
  • 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.
  • if you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • heart disease
  • thyroid disease
  • glaucoma
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • kidney disease. Your doctor should determine if you need a different dose.

When Using This Product

  • do not take more than directed
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
  • the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop Use And Ask A Doctor If

  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • you get nervous, dizzy, or sleepless

If pregnant or breast-feeding, 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 (1-800-222-1222) right away.

Directions

  • do not divide, crush, chew or dissolve the tablet; swallow tablet whole
 adults and children 12 years of age and over  take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
 children under 12 years of age  do not use
 adults 65 years of age and older  ask a doctor
 consumers with kidney disease  ask a doctor

Other information
  • safety sealed: do not use if carton is opened or if individual buler units are torn or opened. 
  • store at 20-25°C (68-77°F).
  • Meets USP dissolution test 7

Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid Questions or Comments? call 1-855-274-4122 IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information. Manufactured for: AUROHEALTH LLC 2572 Brunswick PikeLawrenceville, NJ 08648 Made in IndiaCode: TS/DRUGS/22/2009

Package Label-principal Display Panel - 1 X 10 Blister Carton


AUROHEALTH NDC 58602-807-83 *Compare to the active ingredients in Allegra-D® 12 Hour Allergy & Congestion Tablets Allergy & Congestion Fexofenadine HCl and Pseudoephedrine HCl Extended-Release Tablets USP 60 mg / 120 mg Fexofenadine HCl 60 mg / antihistamine Pseudoephedrine HCl 120 mg / nasal decongestion 12 HOUR Non-Drowsy Indoor / Outdoor Relief Of
  • Nasal and Sinus Congestion Due to Colds or Allergies
  • Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or Throat Due to Allergies    

10 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."

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"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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