Fexofenadine Hydrochloride Tablets Usp, 180 Mg

Fexofenadine Hydrochloride Tablets Usp, 180 Mg
SPL v1
SPL
SPL Set ID e7c4a402-09ca-4f95-86fa-20b6117facb3
Route
ORAL
Published
Effective Date 2015-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Anhydrous Lactose Colloidal Silicon Dioxide Starch, Corn Croscarmellose Sodium Lactose Monohydrate Stearic Acid Hypromelloses Polyethylene Glycols Ferric Oxide Red Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: SG;202 Shape: capsule Color: pink Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2015-09-16

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 55106-9

Fexofenadine HCl USP, 180 mg

Warnings

Directions

 adults and children 12 years of age and over take one 180mg 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

Do Not Use

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

Other Information
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened.
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

Questions Or Comments?

Call 1-888-588-1418

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2015 CVS/pharmacy

CVS.com ® 1-800-SHOP CVS

V-32583

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 A doctor If

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

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.

Ask A Doctor Before Use If You Have

kidney disease. Your doctor should determine if you need a different dose.

Cvs Health Compare to the Active Ingredient in Allegra® Allergy 24 Hour Tablets*


Structured Label Content

Uses

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

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 55106-9 (55106-9)

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine

Warnings

Directions

 adults and children 12 years of age and over take one 180mg 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

Do Not Use (Do not use)

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

Other Information (Other information)
  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened.
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • each tablet contains: sodium 8.2 mg
  • this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients (Inactive ingredients)

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

Questions Or Comments? (Questions or comments?)

Call 1-888-588-1418

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

©2015 CVS/pharmacy

CVS.com ® 1-800-SHOP CVS

V-32583

When Using This Product (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 A doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease. Your doctor should determine if you need a different dose.

Cvs Health Compare to the Active Ingredient in Allegra® Allergy 24 Hour Tablets* (CVS Health-Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets*)


Advanced Ingredient Data


Raw Label Data

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