Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 348b79cf-1184-46d4-a0e5-fdc24afec1a5
Route
ORAL
Published
Effective Date 2024-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (180 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Hypromelloses Ferric Oxide Red Ferric Oxide Yellow Lactose Monohydrate Polyethylene Glycol, Unspecified Titanium Dioxide Anhydrous Lactose Starch, Corn Ferrosoferric Oxide Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: G6 Shape: oval Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-01

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
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.

Product Label
SIGNATURE SELECT Allergy Relief
Other Information
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture



Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized starch, polyethylene glycol, magnesium stearate, microcrystalline cellulose, titanium dioxide,

Questions Or Comments?

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Allegra® Allergy 24 Hr active ingredient*

ALLERGY RELIEF

FEXOFENADINE HCI 180mg

Antihistamine Tablets

Original prescription strength

Indoor & outdoor allergies

Relief of:

  • Sneezing, runny nose, itchy nose or throat & itchy, watery eyes

CAPLETS**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 HR.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX, 99

PLEASANT, CA 94566-0009

 

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 (1-800-222-1222) 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 other upper respiratory allergies:

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

Product Label
SIGNATURE SELECT Allergy Relief
Other Information (Other information)
  • store between 20-25ºC (68-77ºF)
  • protect from excessive moisture



Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, pregelatinized starch, polyethylene glycol, magnesium stearate, microcrystalline cellulose, titanium dioxide,

Questions Or Comments? (Questions or comments?)

call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO Allegra® Allergy 24 Hr active ingredient*

ALLERGY RELIEF

FEXOFENADINE HCI 180mg

Antihistamine Tablets

Original prescription strength

Indoor & outdoor allergies

Relief of:

  • Sneezing, runny nose, itchy nose or throat & itchy, watery eyes

CAPLETS**

(**Capsule-shaped tablets)

*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 HR.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX, 99

PLEASANT, CA 94566-0009

 

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 (1-800-222-1222) 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

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