Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • Contains inactivated NDC Code(s)
    NDC Code(s):     62756-542-64, 62756-542-66, 62756-542-74, 62756-542-76, view more
    62756-542-77, 62756-542-78, 62756-542-83, 62756-542-88, 62756-543-64, 62756-543-66, 62756-543-74, 62756-543-76, 62756-543-77, 62756-543-78, 62756-543-83, 62756-543-88, 62756-545-64, 62756-545-66, 62756-545-74, 62756-545-76, 62756-545-77, 62756-545-78, 62756-545-83, 62756-545-88
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 26, 2018

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  • Active ingredient (in each tablet)


    For 30 mg:
    Fexofenadine HCl, USP 30 mg

    For 60 mg:
    Fexofenadine HCl, USP 60 mg

    For 180 mg:
    Fexofenadine HCl, USP 180 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 aluminum 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


    For 30mg:


    adults and children 12 years of age and over
    		take two 30 mg tablets with water every 12 hours; do not take more than 4 tablets in 24 hours
    children 6 to under 12 years of age take one 30 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
    children under 6 years of age
    		do not use
    adults 65 years of age and older
    		ask a doctor
    consumers with kidney disease
    		ask a doctor

    For 60mg:


    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
    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

    For 180mg:


    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
  • Other information

    • safety sealed; do not use if inner safety seal is open or torn
    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
  • Inactive ingredients


    crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, titanium dioxide

  • Questions?


    Call toll free 1-800-818-4555 weekdays

  • Principal Display Panel


    For 30 mg Allergy:

    ORIGINAL PRESCRIPTION STRENGTH
    NDC 62756-542-88
    Children's
    Fexofenadine Hydrochloride Tablets, USP
    30 mg
    ALLERGY
    (12 Hour)
    Antihistamine
    Indoor and Outdoor Allergies
    100 Tablets 30 mg each
    SUN PHARMA

    30mg-allergy-2
    30mg-allergy-3
    30mg-allergy-4
    30mg-allergy-5
    30mg-allergy-6
    30mg-allergy-7
    For 60 mg Allergy:



    NDC 62756-543-88
    Fexofenadine Hydrochloride Tablets, USP
    60 mg
    ALLERGY
    (12 Hour)
    Antihistamine
    Indoor and Outdoor Allergies
    100 Tablets 60 mg each
    SUN PHARMA


    60mg-allergy-1

    60mg-allergy-2

    60mg-allergy-3
    For 180 mg Allergy:

    NDC 62756-545-88
    Fexofenadine Hydrochloride Tablets, USP
    180 mg
    ALLERGY
    (24 Hour)
    Antihistamine
    Indoor and Outdoor Allergies
    100 Tablets 180 mg each
    SUN PHARMA


    180mg-allergy-1

    180mg-allergy-2
  • Principal Display Panel

    For 30 mg Allergy:

    NDC 62756-542-74
    ORIGINAL PRESCRIPTION STRENGTH 
    NON-DROWSY
    Children's
    Fexofenadine Hydrochloride Tablets, USP
    30 mg
    ALLERGY
    (12 Hour)
    Antihistamine
    Indoor and Outdoor Allergies
    Ages 6 years and Older
    Relief of:
    - Sneezing
    - Runny Nose
    - Itchy, Watery Eyes
    - Itchy Nose or Throat
    5 (1 x 5)Tablets 30 mg each
    SUN PHARMA
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
    30mg-allergy-sb

  • Principal Display Panel

    For 60 mg Allergy:

    NDC 62756-543-74
    ORIGINAL PRESCRIPTION STRENGTH
    NON-DROWSY
    Fexofenadine Hydrochloride Tablets, USP
    60 mg
    ALLERGY
    (12 Hour)
    Antihistamine
    Indoor and Outdoor Allergies
    Relief of:
    - Sneezing
    - Runny Nose
    - Itchy, Watery Eyes
    - Itchy Nose or Throat
    5 (1 x 5)Tablets 60 mg each
    SUN PHARMA
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
    60mg-allergy-sb

  • Principal Display Panel

    For 180 mg Allergy:

    NDC 62756-545-74
    ORIGINAL PRESCRIPTION STRENGTH
    NON-DROWSY
    Fexofenadine Hydrochloride Tablets, USP
    180 mg
    ALLERGY
    (24 Hour)
    Antihistamine
    Indoor and Outdoor Allergies
    Relief of:
    - Sneezing
    - Runny Nose
    - Itchy, Watery Eyes
    - Itchy Nose or Throat
    5 (1 x 5)Tablets 180 mg each
    SUN PHARMA
    DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN

    180mg-allergy-sb

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-542
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUND (circular) Size6mm
    FlavorImprint Code 542
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-542-8330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    2NDC:62756-542-88100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    3NDC:62756-542-741 in 1 CARTON02/06/2012
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-542-662 in 1 CARTON02/06/2012
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-542-779 in 1 CARTON02/06/2012
    55 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-542-645 in 1 CARTON02/06/2012
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:62756-542-7610 in 1 CARTON02/06/2012
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:62756-542-7815 in 1 CARTON02/06/2012
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156702/06/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-543
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 543
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-543-8330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    2NDC:62756-543-88100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    3NDC:62756-543-741 in 1 CARTON02/06/2012
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-543-662 in 1 CARTON02/06/2012
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-543-779 in 1 CARTON02/06/2012
    55 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-543-645 in 1 CARTON02/06/2012
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:62756-543-7610 in 1 CARTON02/06/2012
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:62756-543-7815 in 1 CARTON02/06/2012
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156702/06/2012
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-545
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 545
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62756-545-8330 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    2NDC:62756-545-88100 in 1 BOTTLE; Type 0: Not a Combination Product02/06/2012
    3NDC:62756-545-741 in 1 CARTON02/06/2012
    35 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:62756-545-662 in 1 CARTON02/06/2012
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:62756-545-779 in 1 CARTON02/06/2012
    55 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:62756-545-645 in 1 CARTON02/06/2012
    66 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:62756-545-7610 in 1 CARTON02/06/2012
    76 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:62756-545-7815 in 1 CARTON02/06/2012
    86 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09156702/06/2012
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-542, 62756-543, 62756-545) , LABEL(62756-542, 62756-545) , MANUFACTURE(62756-542, 62756-543, 62756-545) , PACK(62756-542, 62756-545)
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