FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated

Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Fexofenadine HCl USP, 60 mg (for 60 mg)

Fexofenadine HCl USP, 180 mg (for 180 mg)

Purpose

Antihistamine

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.

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

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

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.

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

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

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 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 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 - 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 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

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 

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE  
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-889
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (PEACH)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	G5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-889-51	1 in 1 CARTON	11/07/2023
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 62207-889-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2023
3	NDC: 62207-889-60	8 in 1 CARTON	11/07/2023
3		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	11/07/2023

FEXOFENADINE HYDROCHLORIDE  
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-891
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (PEACH)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	17mm
Flavor		Imprint Code	G6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-891-51	1 in 1 CARTON	11/07/2023
1		10 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 62207-891-49	1000 in 1 BOTTLE; Type 0: Not a Combination Product	11/07/2023
3	NDC: 62207-891-58	7 in 1 CARTON	11/07/2023
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	11/07/2023

Labeler - Granules India Limited (915000087)