Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated

  • Contains inactivated NDC Code(s)
    NDC Code(s):     68554-5061-0, 68554-5061-1, 68554-5061-2, 68554-5061-3, view more
    68554-5061-4, 68554-5061-5, 68554-5061-6, 68554-5062-0, 68554-5062-1, 68554-5062-2, 68554-5062-3, 68554-5062-4, 68554-5062-5, 68554-5062-6, 68554-5063-0, 68554-5063-1, 68554-5063-2, 68554-5063-3, 68554-5063-4, 68554-5063-5, 68554-5063-6
  • Packager: Hetero Labs Limited
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 8, 2016

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  • ACTIVE INGREDIENT(S)

    (in each tablet)
    Fexofenadine Hydrochloride USP, 30 mg
    Fexofenadine Hydrochloride USP, 60 mg
    Fexofenadine Hydrochloride USP, 180 mg

  • PURPOSE

    Antihistamine

  • USE(S)

    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.

  • PREGNANCY/BREASTFEEDING

    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

    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

    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

    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

    • Tamper Evident: Do not use if printed foil seal under cap is missing
    • This unit-dose package is not child-resistant
    • store between 20º and 25ºC (68º and 77ºF) 
    • protect from excessive moisture
  • INACTIVE INGREDIENTS

    Colloidal silicon dioxide, hypromellose, light liquid paraffin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, red iron oxide, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.

  • QUESTIONS?

    Call 1-866-495-1995

  • PRINCIPAL DISPLAY PANEL

    Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Carton


    Fexofenadine30mg30scarton




    Fexofenadine Hydrochloride Tablets USP, 30 mg - Container Label


    Fexofendine30mg30slabel





    Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Foil


    Fexofendine30mg10sfoil




    Fexofenadine Hydrochloride Tablets USP, 30 mg - Blister Carton



    Fexofendine30mg10scarton


    Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Carton


    Fexofenadine60mg30scarton






    Fexofenadine Hydrochloride Tablets USP, 60 mg - Container Label


    Fexofenadine60mg30slabel



    Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Foil


    Fexofenadine60mg10sfoil



    Fexofenadine Hydrochloride Tablets USP, 60 mg - Blister Carton


    Fexofenadine60mg10scarton



    Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Carton


    Fexofenadine180mg30scarton


    Fexofenadine Hydrochloride Tablets USP, 180 mg - Container Label


    Fexofendine180mg30slabel


    Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Foil


    Fexofendine180mg10sfoil


    Fexofenadine Hydrochloride Tablets USP, 180 mg - Blister Carton


    Fexofenadine180mg10scarton

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5061
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUND (biconvex) Size6mm
    FlavorImprint Code j;42
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68554-5061-01 in 1 CARTON08/23/2016
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68554-5061-11 in 1 CARTON08/23/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68554-5061-21 in 1 CARTON08/23/2016
    3500 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68554-5061-510 in 1 CARTON08/23/2016
    4NDC:68554-5061-410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:68554-5061-622 in 1 CARTON08/23/2016
    5NDC:68554-5061-310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409708/23/2016
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5062
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVAL (biconvex) Size12mm
    FlavorImprint Code j;43
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68554-5062-01 in 1 CARTON08/23/2016
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68554-5062-11 in 1 CARTON08/23/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68554-5062-21 in 1 CARTON08/23/2016
    3500 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68554-5062-57 in 1 CARTON08/23/2016
    4NDC:68554-5062-410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:68554-5062-615 in 1 CARTON08/23/2016
    5NDC:68554-5062-310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409708/23/2016
    FEXOFENADINE HYDROCHLORIDE 
    fexofenadine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68554-5063
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULE (biconvex) Size18mm
    FlavorImprint Code j;44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68554-5063-01 in 1 CARTON08/23/2016
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68554-5063-11 in 1 CARTON08/23/2016
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68554-5063-21 in 1 CARTON08/23/2016
    3500 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:68554-5063-57 in 1 CARTON08/23/2016
    4NDC:68554-5063-410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:68554-5063-615 in 1 CARTON08/23/2016
    5NDC:68554-5063-310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20409708/23/2016
    Labeler - Hetero Labs Limited (917261950)
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