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Fexofenadine Hydrochloride by Chain Drug Marketing Associate

Medically reviewed on January 22, 2018

Dosage form: tablet
Ingredients: Fexofenadine Hydrochloride 180mg
Labeler: Chain Drug Marketing Associate
NDC Code: 63868-025

Fexofenadine HCl Tablets USP

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

Allergy

temporarily relieves these symptoms due to hay fever or otherupper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Hives

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction  from occuring.



Warnings

Hives

Severe Allergic Warning: Get emergency help immediately if you have hives along with any of the following symptom:

  • trouble swallowing  
  • dizziness or loss of consciousness 
  • swelling of tongue  
  • swelling in or around mouth 
  • trouble speaking 
  • drooling 
  • wheezing or problems breathing  

These symptoms may be signs of anaphylactic shock. This condition canbe life threatening if not treated by a health professional immediately.Symptoms of anaphylactic shock may occur when hives first appear or upto a few hours later.

Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrineinjector for “anaphylaxis” or severe allergy symptoms that could occur withyour hives, never use this product as a substitute for the epinephrine injector.If you have been prescribed an epinephrine injector, you should carry it withyou at all times.

Do not use

Allergy

if you have ever had an allergic reaction to this product or any of its ingredients.

Hives

  • to prevent hives from any known cause such as: 
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

Allergy

  • kidney disease. Your doctorshould determine if you need a different dose.

Hives

  • kidney disease. Your doctor should determine if you need a different dose.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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)

Stop use and ask doctor if

Allergy

an allergic reaction to this product occurs. Seek medical help right away.

Hives

  • an allergic reaction to this product occurs. Seek medical help right away.

  • symptoms do not improve after 3 days of treatment

  • the hives have lasted more than 6 weeks

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 right away.

Directions

180 mg

adults and children 12 years of age and over         take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
Adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

safety sealed: do not use if carton is opened or if individual blister units are torn or opened.

Storage

store between 20° - 25°C (68° - 77°F)

protect from excessive moisture

this product meets the requirements of USP Dissolution Test 2.

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, mannitol, and powdered cellulose, opadry pink 03B54504 containing FD&C Red no. 40, hypromellose, iron oxide black, polyethylene glycol and titanium dioxide.

Questions or comments?

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

containercarton

Container Carton Label: 30 count

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-025(NDC:55111-784)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fexofenadine Hydrochloride (FEXOFENADINE) Fexofenadine Hydrochloride180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
magnesium stearate 
mannitol 
POWDERED CELLULOSE 
FD&C RED NO. 40 
HYPROMELLOSE 2910 (6 MPA.S) 
FERROSOFERRIC OXIDE 
polyethylene glycol 400 
TITANIUM DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize7mm
FlavorImprint Code194;R
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-025-301 BOTTLE in 1 CARTON
130 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07650204/01/2014
Labeler - Chain Drug Marketing Associate (011920774)

 
Chain Drug Marketing Associate

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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