Fexofenadine Hcl Tablets, Usp 

Fexofenadine Hcl Tablets, Usp 
SPL v1
SPL
SPL Set ID f7784610-7ca5-4489-b391-f2b3f3f6549b
Route
ORAL
Published
Effective Date 2023-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fexofenadine (60 mg)
Inactive Ingredients
Croscarmellose Sodium Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Hypromellose 2910 (15 Mpa.s) Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 6000 Silicon Dioxide Starch, Corn Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-12-18

Description

Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 180 mg)

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Fexofenadine HCl USP 60 mg (for 60 mg) Fexofenadine HCl USP 180 mg (for 180 mg)

Uses

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

  • runny nose 
  • sneezing 
  • itchy, watery eyes
  •  itching of the nose or throat
Section 51945-4

C'rcle Allergy Relief

Fexofenadine HCl Tablets, USP 60 mg

Antihistamine

100 Tablets

NDC 57483-240-02

C'rcle Allergy Relief

Fexofenadine HCl Tablets, USP 180 mg

Antihistamine

150 Tablets

Warnings

Directions
adults and children 12 years of age and over         

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg)

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 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.

Other Information
  • Safety-sealed: do not use if imprinted foil under bottle cap is opened or torn.
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
Active Ingredient 

Fexofenadine HCl USP 60 mg (for 60 mg)

Fexofenadine HCl USP 180 mg (for 180 mg)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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)
If Pregnant Or Breast Feeding

 ask a health professional before use.

Stop Use and Ask A Doctor If 

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

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.


Structured Label Content

Uses

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

  • runny nose 
  • sneezing 
  • itchy, watery eyes
  •  itching of the nose or throat
Section 51945-4 (51945-4)

C'rcle Allergy Relief

Fexofenadine HCl Tablets, USP 60 mg

Antihistamine

100 Tablets

NDC 57483-240-02

C'rcle Allergy Relief

Fexofenadine HCl Tablets, USP 180 mg

Antihistamine

150 Tablets

Purpose

Antihistamine

Warnings

Directions
adults and children 12 years of age and over         

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg)

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 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST.

Other Information (Other information)
  • Safety-sealed: do not use if imprinted foil under bottle cap is opened or torn.
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
Active Ingredient  (Active ingredient )

Fexofenadine HCl USP 60 mg (for 60 mg)

Fexofenadine HCl USP 180 mg (for 180 mg)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, 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)
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

 ask a health professional before use.

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.

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.


Advanced Ingredient Data


Raw Label Data

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