Fexofenadine hydrochloride tablet, film coated

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 under12 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 under12 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 20and 25C (68and 77F)
  • protect from excessive moisture and light

Inactive ingredients



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

Questions or comments?


call 1-855-274-4122

Ingredients and appearance - Product information

Fexofenadine hydrochloride tablet, film coated- Fexofenadine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 70677-0008
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 180 mgin 1

Inactive Ingredients

Ingredient Name Code
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) Shape CAPSULE (Bevel Edge, Biconvex)
Size 17 mm Score 1
Imprint Code E;44

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 70677-0008-2 30 in 1 BOTTLE 2016/10/12
2 NDC: 70677-0008-1 15 in 1 BLISTER PACK 2016/10/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202039 USA 2016/10/12

Fexofenadine hydrochloride tablet, film coated- Fexofenadine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 70677-0007
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fexofenadine hydrochloride ( UNII: 2S068B75ZU)( Fexofenadine - UNII: E6582LOH6V ) 60 mgin 1

Inactive Ingredients

Ingredient Name Code
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) Shape CAPSULE (Bevel Edge, Biconvex)
Size 12 mm Score 1
Imprint Code E;42

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 70677-0007-1 12 in 1 BLISTER PACK 2016/10/12

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA202039 USA 2016/10/12

Labeler - Sunmark( 116956644)

Establishment

Name ID/FEI Business Operations
Sunmark 116956644 MANUFACTURE( 70677-0007, 70677-0008)

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
R
unny 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
R
unny nose
Itchy, Watery Eyes
Itchy Throat or Nose


DO NOT USE IF FOIL SEAL IS TORN OR MISSING

12 Tablets 60 mg each