Fexofenadine Hcl Tablets Usp

Fexofenadine Hcl Tablets Usp
SPL v9
SPL
SPL Set ID 204506d7-7688-fd7e-0aae-142b698848ef
Route
ORAL
Published
Effective Date 2016-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
ANDA Active Since 2011-04-01 Until 2023-01-30

Description

Fexofenadine HCl USP, 180 mg

Purpose

Antihistamine


Medication Information

Warnings and Precautions

Purpose

Antihistamine

Description

Fexofenadine HCl USP, 180 mg

Uses

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

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





Warnings

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
Do Not Use

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

Questions?

Call 1-888-375-3784

Bottle Label

Bottle Label: 180 count

CVS Health

Compare to the active ingedient in

Allegra® Allergy 24 Hour Tablets*

Indoor & Outdoor Alllergies

Allergy Relief

FEXOFENADINE HYDROCHLORIDE

TABLETS USP, 180 MG

24 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Non-Drowsy 24 HOUR

Actual Bottle Size on Bottom Panel

Package Contains One Bottle

Carton Label

Carton Label: 180 count

CVS Health

Compare to the active ingedient in

Allegra® Allergy 24 Hour Tablets*

Indoor & Outdoor Alllergies

Allergy Relief

FEXOFENADINE HYDROCHLORIDE

TABLETS USP, 180 MG

24 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Non-Drowsy 24 HOUR

Actual Bottle Size on Bottom Panel

Package Contains One Bottle

Other Information

  • (Bottle only)-safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
  • (Blister only)- Safety sealed: Do not use if seal is broken or if individual blister unit is torn or open
  • store between 20° and 25°C (68° and 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, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide.

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

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.

Active Ingredient (in Each Tablet)

Fexofenadine HCl USP, 180 mg

Ask A Doctor Before Use If You Have

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


Structured Label Content

Uses

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

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





Warnings and Precautions (34071-1)

Purpose

Antihistamine

Warnings

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
Do Not Use (Do not use)

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

Questions?

Call 1-888-375-3784

Bottle Label

Bottle Label: 180 count

CVS Health

Compare to the active ingedient in

Allegra® Allergy 24 Hour Tablets*

Indoor & Outdoor Alllergies

Allergy Relief

FEXOFENADINE HYDROCHLORIDE

TABLETS USP, 180 MG

24 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Non-Drowsy 24 HOUR

Actual Bottle Size on Bottom Panel

Package Contains One Bottle

Carton Label (Carton label)

Carton Label: 180 count

CVS Health

Compare to the active ingedient in

Allegra® Allergy 24 Hour Tablets*

Indoor & Outdoor Alllergies

Allergy Relief

FEXOFENADINE HYDROCHLORIDE

TABLETS USP, 180 MG

24 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy nose or throat

Non-Drowsy 24 HOUR

Actual Bottle Size on Bottom Panel

Package Contains One Bottle

Other Information (Other information)

  • (Bottle only)-safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
  • (Blister only)- Safety sealed: Do not use if seal is broken or if individual blister unit is torn or open
  • store between 20° and 25°C (68° and 77°F)
  • protect from excessive moisture
  • this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide.

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 Doctor If (Stop use and ask 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Fexofenadine HCl USP, 180 mg

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)