Fexofenadine Hcl Tablets Usp, 60 Mg And 180 Mg

Fexofenadine Hcl Tablets Usp, 60 Mg And 180 Mg
SPL v3
SPL
SPL Set ID e0537b71-fdee-4122-9c09-868ce7352080
Route
ORAL
Published
Effective Date 2023-11-07
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

Pill Appearance
Imprint: G6 Shape: oval Shape: capsule Color: orange Size: 12 mm Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2023-11-07

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

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning:Get emergency help immediatelyif you have hives along with any of the following symptoms:

  • trouble swallowing 
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • wheezing or problems breathing
  • drooling

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine.If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

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
  •  to preventhives from any known cause such as:
  • foods
  • insect stings
  • medicines
  • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • if you have ever had an allergic reaction to this product or any of its ingredients
Other Information
  • safety sealed: do not use if foil printed with granules logo under bottle cap is opened or torn.
  • store between 20º and 25ºC (68º and 77ºF)
  • protect from excessive moisture
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.

Questions Or Comments?

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



Manufactured By:

Granules India Limited    

Hyderabad-500 081, India

 

MADE IN INDIA



Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks
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, 60 mg (for 60 mg)



Fexofenadine HCl USP, 180 mg (for 180 mg)

Ask A Doctor Before Use If You Have
  • kidney disease. Your doctor should determine if you need a different dose.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch
Principal Display Panel 60 Mg Blister Carton

NDC 62207-889-60               

                                                                                  New!

                                                                NON-DROWSY

Fexofenadine HCl  Tablets USP, 60 mg

  Hives

Antihistamine

REDUCES HIVES and                            12 HR

RELIEVES ITCHING

due to hives

                              

                                                                         72 (8 x 9) Tablets

*Compare to the active ingredient in  Allegra ® Hives 12 HOUR



Principal Display Panel 180 Mg Blister Carton

NDC 62207-891-58                                              New!

                                                            NON-DROWSY

Fexofenadine HCl  Tablets USP, 180 mg

Hives

Antihistamine

 

REDUCES HIVES and                         24 HR

RELIEVES ITCHING

due to hives

 

                                                             70 (7 x 10) Tablets

*Compare to the active ingredient in  Allegra ® Hives 24 HOUR 



Principal Display Panel 60 Mg 10s Container Label

NDC 62207-889-51                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP 60 mg

Hives

Antihistamine

REDUCES HIVES and            12 HR

RELIEVES ITCHING

due to hives

 

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 12 HOUR 

Principal Display Panel 180 Mg 10s Container Label

NDC 62207-891-51                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP 180 mg

Hives

Antihistamine

REDUCES HIVES and           24 HR

RELIEVES ITCHING

due to hives

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 24 HOUR 



Principal Display Panel 60 Mg 10s Container Carton

NDC 62207-889-51                 

                                                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP

60 mg

  Hives

Antihistamine

REDUCES HIVES and            

RELIEVES ITCHING

due to hives

                                              12 HR

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 12 HOUR



Principal Display Panel 180 Mg 10s Container Carton

NDC 62207-891-51                 

                                                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP

180 mg

Hives

Antihistamine

REDUCES HIVES and             24 HR

RELIEVES ITCHING

due to hives

                                              

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 24 HOUR




Structured Label Content

Uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Purpose

Antihistamine

Warnings

Severe Allergy Warning:Get emergency help immediatelyif you have hives along with any of the following symptoms:

  • trouble swallowing 
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • wheezing or problems breathing
  • drooling

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine.If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

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)
  •  to preventhives from any known cause such as:
  • foods
  • insect stings
  • medicines
  • latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

  • 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 foil printed with granules logo under bottle cap is opened or torn.
  • store between 20º and 25ºC (68º and 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, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide.

Questions Or Comments? (Questions or comments?)

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



Manufactured By:

Granules India Limited    

Hyderabad-500 081, India

 

MADE IN INDIA



Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054

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.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks
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, 60 mg (for 60 mg)



Fexofenadine HCl USP, 180 mg (for 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch
Principal Display Panel 60 Mg Blister Carton (PRINCIPAL DISPLAY PANEL 60 mg - Blister Carton)

NDC 62207-889-60               

                                                                                  New!

                                                                NON-DROWSY

Fexofenadine HCl  Tablets USP, 60 mg

  Hives

Antihistamine

REDUCES HIVES and                            12 HR

RELIEVES ITCHING

due to hives

                              

                                                                         72 (8 x 9) Tablets

*Compare to the active ingredient in  Allegra ® Hives 12 HOUR



Principal Display Panel 180 Mg Blister Carton (PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton)

NDC 62207-891-58                                              New!

                                                            NON-DROWSY

Fexofenadine HCl  Tablets USP, 180 mg

Hives

Antihistamine

 

REDUCES HIVES and                         24 HR

RELIEVES ITCHING

due to hives

 

                                                             70 (7 x 10) Tablets

*Compare to the active ingredient in  Allegra ® Hives 24 HOUR 



Principal Display Panel 60 Mg 10s Container Label (PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Label)

NDC 62207-889-51                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP 60 mg

Hives

Antihistamine

REDUCES HIVES and            12 HR

RELIEVES ITCHING

due to hives

 

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 12 HOUR 

Principal Display Panel 180 Mg 10s Container Label (PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Label)

NDC 62207-891-51                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP 180 mg

Hives

Antihistamine

REDUCES HIVES and           24 HR

RELIEVES ITCHING

due to hives

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 24 HOUR 



Principal Display Panel 60 Mg 10s Container Carton (PRINCIPAL DISPLAY PANEL 60 mg - 10s Container Carton)

NDC 62207-889-51                 

                                                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP

60 mg

  Hives

Antihistamine

REDUCES HIVES and            

RELIEVES ITCHING

due to hives

                                              12 HR

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 12 HOUR



Principal Display Panel 180 Mg 10s Container Carton (PRINCIPAL DISPLAY PANEL 180 mg - 10s Container Carton)

NDC 62207-891-51                 

                                                    New!

                                  NON-DROWSY

Fexofenadine HCl

Tablets, USP

180 mg

Hives

Antihistamine

REDUCES HIVES and             24 HR

RELIEVES ITCHING

due to hives

                                              

10 Tablets

*Compare to the active ingredient in

Allegra ® Hives 24 HOUR




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)