Label: FEXOFENADINE HCL tablet, film coated

  • NDC Code(s): 69230-201-05, 69230-202-01, 69230-202-05, 69230-202-11, view more
    69230-202-30, 69230-202-45, 69230-202-60, 69230-202-90
  • Packager: Camber Consumer Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 13, 2021

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

  • ALLERGY Active ingredient (in each film-coated tablet)

    Fexofenadine HCl USP, 60mg and 180 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • itchy, watery eyes
    • sneezing
    • 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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1800-222-1222).

  • Directions

    FOR 60mg
    adults and children 12 years of age and overtake two 60mg tablets with water evrery 12 hours; do not take more than 2 tablets in 24 hours
    children under 12 years of agedo not use
    adults 65 years of age and olderask a doctor
    consumers with kidney diseaseask a doctor
    FOR 180mg
    adults and children 12 years of age and overtake one 180mg 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 printed foil inner seal on bottle is torn or missing
    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
    • each tablet contains: sodium 8.2 mg (for 180mg)
    • each tablet contains: sodium 2.7 mg (for 60mg)
    • this product meets the requirements of USP Dissolution Test 2
  • Inactive ingredients

    anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch (maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide, titanium dioxide and yellow iron oxide.

  • Questions or comments?

    Call 1-888-588-1418

    Distributed by:
    Camber Consumer Care, Inc.
    Piscataway, NJ 08854, USA,

    Made in USA

  • Camber Consumer Care - Compare to the active ingredient in Allegra® Allergy 24 Hour Tablets Allergy Relief - 24 HOUR FEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mg Antihistamine Indoor & Outdoor Allergies

    180 mg

  • CAMBER CONSUMER CARE

    NDC 69230-201-05 Compare to the active ingredient in Allegra® Allergy*

    Non-Drowsy

    Fexofenadine Hydrochloride Tablets USP

    60 mg

    Antihistamine

    12 HR Indoor/Outdoor Allergy Relief

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Nose or Throat

    60 mg

  • INGREDIENTS AND APPEARANCE
    FEXOFENADINE HCL 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-202
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code SG;202
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-202-301 in 1 CARTON09/16/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-202-451 in 1 CARTON09/16/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69230-202-601 in 1 CARTON09/16/2015
    360 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:69230-202-901 in 1 CARTON09/16/2015
    490 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69230-202-011 in 1 CARTON09/16/2015
    5100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:69230-202-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2015
    7NDC:69230-202-111000 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450709/16/2015
    FEXOFENADINE HCL 
    fexofenadine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-201
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Modified Oval) Size12mm
    FlavorImprint Code SG;201
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-201-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20450712/08/2021
    Labeler - Camber Consumer Care (079539968)