FEXOFENADINE HYDROCHLORIDE tablet, film coated

Fexofenadine hydrochloride by

Drug Labeling and Warnings

Fexofenadine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Sunmark, Aurolife Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(in each tablet)

Fexofenadine HCl USP, 180 mg

Fexofenadine HCl USP, 60 mg

Purpose

Antihistamine

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

Warnings

Do not use

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.

When using this product

• do not take more than directed
• do not take at the same time as aluminium 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.

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

• 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 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

Other information

• safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing
• store between 20°and 25°C (68°and 77°F)
• protect from excessive moisture and light

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch,croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol 400, pregelatinized corn starch, red iron oxide, steric acid, titanium dioxide, and yellow iron oxide,

Questions or comments?

 call 1-855-274-4122

Principal Display Panel

NDC: 70677-0008-2

Original Prescription Strength
Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
 
Allergy
Indoor & Outdoor Allergies

24 Hours Relief of: 

 Sneezing
 Runny nose
Itchy, Watery Eyes
Itchy Throat or Nose 


DO NOT USE IF FOIL SEAL IS TORN OR MISSING

30 Tablets 180 mg each

Principal Display Panel

NDC: 70677-0007-1

Original Prescription Strength
Non-Drowsy

Fexofenadine Hydrochloride Tablets USP, 60 mg/antihistamine
 
Allergy 
Indoor & Outdoor Allergies

12 Hours Relief of: 

 Sneezing 
 Runny nose
Itchy, Watery Eyes
Itchy Throat or Nose 


DO NOT USE IF FOIL SEAL IS TORN OR MISSING 

12 Tablets 60 mg each

INGREDIENTS AND APPEARANCE

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-0008
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (Peach)	Score	no score
Shape	CAPSULE (Bevel Edge, Biconvex)	Size	17mm
Flavor		Imprint Code	E;44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-0008-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/12/2016
2	NDC: 70677-0008-1	15 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202039	10/12/2016

FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-0007
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	CAPSULE (Bevel Edge, Biconvex)	Size	12mm
Flavor		Imprint Code	E;42
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-0007-1	12 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202039	10/12/2016

Labeler - Sunmark (116956644)

Registrant - Aurolife Pharma, LLC (829084461)

Establishment
Name	Address	ID/FEI	Business Operations
Aurolife Pharma, LLC		829084461	MANUFACTURE(70677-0007, 70677-0008)