Fexofenadine Hcl Tablets Usp

Fexofenadine Hcl Tablets Usp
SPL v4
SPL
SPL Set ID f532e9d5-6457-8bef-e83e-16050f20b03c
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 2012-04-12

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 other upper respiratory allergies:

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




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 toll-free 1-888-375-3784

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
  • 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.

Allergy Relief (fexofenadine Hydrochloride Usp) Tablets 180 Mg 15 Count Carton

FAMILY wellness™

COMPARE TO THE ACTIVE INGREDIENT OF ALLREGRA® ALLERGY 24 HOUR TABLETS*

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Original Prescription Strength

NON-DROWSY


Allergy Relief

Fexofenadine Hydrochloride Tablets USP,

180mg / Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Nose or Throat

15 TABLETS 180 mg each

24 HOUR


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




Warnings and Precautions (34071-1)

Purpose

Antihistamine

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 toll-free 1-888-375-3784

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
  • 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.

Allergy Relief (fexofenadine Hydrochloride Usp) Tablets 180 Mg 15 Count Carton (Allergy Relief (fexofenadine hydrochloride USP) Tablets 180 mg 15 count carton)

FAMILY wellness™

COMPARE TO THE ACTIVE INGREDIENT OF ALLREGRA® ALLERGY 24 HOUR TABLETS*

100% SATISFACTION GUARANTEED OR YOUR MONEY BACK

Original Prescription Strength

NON-DROWSY


Allergy Relief

Fexofenadine Hydrochloride Tablets USP,

180mg / Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Nose or Throat

15 TABLETS 180 mg each

24 HOUR


Advanced Ingredient Data


Raw Label Data

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