Fexofenadine hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Fexofenadine hydrochloride

Physicians Total Care, Inc.

Fexofenadine HCl Tablets USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Use(s)

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

  • runny nose
  • itchy, watery eys
  • sneezing
  • itching of the nose or Throad



Warnings

Do not use

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

Ask a doctor before use if

you have kidney disease. Your doctorshould 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)

Stop use and ask doctor if

Allergy

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

Pregnancy/Breastfeeding

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

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 age do not use
Adults 65 years of age  and older ask a doctor
consumers with kidney disease ask a doctor

Fexofenadine hydrochloride 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

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

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Louisiana LLC,

8800 Line Ave Shreveport, LA, 71106. 

OR

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, OK      74146

Principal Display Panel

Fexofenadine HCl USP, 180 mg

NDC 54868-6289-0

Fexofenadine hydrochloride

Fexofenadine hydrochloride

Fexofenadine hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-6289(NDC:55111-784)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FEXOFENADINE HYDROCHLORIDE FEXOFENADINE 180 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
mannitol
POWDERED CELLULOSE
FD&C RED NO. 40
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE BLACK
polyethylene glycol 400
titanium dioxide
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
PINK 7 mm 194;R OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-6289-0 30 in 1 BOTTLE
2 NDC:54868-6289-1 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076502 2011-07-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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