Label: ALLERGY 24-HR- fexofenadine hydrochloride tablet, film coated

  • NDC Code(s): 64679-744-08, 64679-744-09, 64679-982-08, 64679-982-09, view more
    64679-987-05, 64679-987-09, 64679-987-10, 64679-987-11, 64679-987-12, 64679-987-13, 64679-987-14, 64679-987-16, 64679-987-17, 64679-987-20, 64679-987-22, 64679-987-24
  • Packager: Wockhardt USA LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2021

If you are a consumer or patient please visit this version.

  • OTC - ACTIVE INGREDIENT SECTION

    For 30 mg:

    Fexofenadine HCl 30 mg

    For 60 mg:

    Fexofenadine HCl 60 mg

    For 180 mg:

    Fexofenadine HCl 180 mg

  • OTC - PURPOSE SECTION

    Antihistamine

  • USAGE

    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 a 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.

  • OTC - KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE AND ADMINISTRATION

    For 30 mg:

    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 60 mg:

    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 180 mg:

    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 carton is opened or if inner seal imprinted with "Sealed for Your Protection" is missing or torn
    • safety sealed: do not use if carton is opened or if individual blister unit is torn or open
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
  • INACTIVE INGREDIENT

    For 30 mg

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

    For 60 mg

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

    For 180 mg

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone K-30, talc, titanium dioxide

  • Questions or comments?

    Call toll-free 1-800-346-6854

    Manufactured by:

    Patheon Puerto Rico, Inc.,

    Manati, PR 00674

    Distributed by:

    Wockhardt USA LLC

    20 Waterview Blvd.

    Parippany, NJ 07054

    USA.

    Rev.06-15

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Fexofenadine hydrochloride

    Film-coated Tablets

    Indoor and Outdoor Allergies – 24 hours

    180 mg

    30 tablets bottle pack

    30T Bottle Pack

    Fexofenadine hydrochloride

    Film-coated Tablets

    Indoor and Outdoor Allergies – 24 hours

    180 mg

    90 tablets bottle pack

    90T-Bottle Pack

    Fexofenadine hydrochloride

    Film-coated Tablets

    Indoor and Outdoor Allergies – 24 hours

    180 mg

    5 tablets blister carton

    5T-Blister pack carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY 24-HR  
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-744
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code W;30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-744-091 in 1 CARTON02/08/2012
    1NDC:64679-744-086 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911202/08/2012
    ALLERGY 24-HR  
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-982
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (light peach to peach) Scoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code W982
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-982-092 in 1 CARTON02/08/2012
    1NDC:64679-982-086 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911202/08/2012
    ALLERGY 24-HR  
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64679-987
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorbrown (light peach to peach) Scoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code W987
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64679-987-101 in 1 CARTON02/08/2012
    1NDC:64679-987-095 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:64679-987-113 in 1 CARTON02/08/2012
    2NDC:64679-987-095 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:64679-987-052000 in 1 POUCH; Type 0: Not a Combination Product02/08/2012
    4NDC:64679-987-201 in 1 CARTON02/08/2012
    4NDC:64679-987-1230 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:64679-987-241 in 1 CARTON02/08/2012
    5NDC:64679-987-1690 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:64679-987-142 in 1 CARTON02/08/2012
    6NDC:64679-987-1345 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:64679-987-171000 in 1 BOTTLE; Type 0: Not a Combination Product02/08/2012
    8NDC:64679-987-221 in 1 CARTON02/08/2012
    8NDC:64679-987-1345 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07911202/08/2012
    Labeler - Wockhardt USA LLC. (170508365)
    Registrant - Wockhardt Limited (650069115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Puerto Rico, Inc.143814544analysis(64679-982, 64679-987) , label(64679-982, 64679-987) , manufacture(64679-982, 64679-987) , pack(64679-982, 64679-987)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wockhardt Limited676257570analysis(64679-744, 64679-982, 64679-987) , manufacture(64679-744, 64679-982, 64679-987) , label(64679-744, 64679-982, 64679-987) , pack(64679-744, 64679-982, 64679-987)