Label: UP AND UP NON DROWSY ALLERGY RELIEF- fexofenadine hydrochloride tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 11, 2024

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  • Active ingredient (in each tablet)

    Fexofenadine HCl 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 (1-800-222-1222).

  • 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 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

    •
    do not use if printed foil under cap is broken or missing
    •
    store between 20°-25°C (68°-77°F)
    •
    protect from excessive moisture
    •
    this product meets the requirements of USP Dissolution Test 2
  • Inactive ingredients

    colloidal silicone dioxide, croscarmellose sodium, D&C red #27 aluminum lake, FD&C blue #1 aluminum lake, gelatin, glycerin, lactose monohydrate, lecithin, magnesium stearate, maltitol solution, medium chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-888-547-7400

  • Package/Label Principal Display Panel

    Compare to active ingredient in Allegra® Allergy

    Non-Drowsy Allergy Relief

    Fexofenadine Hydrochloride Tablets 180 mg / Antihistamine

    Indoor and outdoor allergy relief of sneezing; runny nose; itchy, watery eyes; itchy nose or throat

    24 Hour

    GCP

    up&up™

    60 GELTABS*, 180 mg EACH

    *GELATIN COATED TABLETS

    Actual Size 60 Geltabs*

    3r6-uw-non-drowsy-allergy-relief
  • INGREDIENTS AND APPEARANCE
    UP AND UP NON DROWSY ALLERGY RELIEF 
    fexofenadine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82442-300
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTITOL (UNII: D65DG142WK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE, PURPLEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code GCP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82442-300-721 in 1 CARTON03/04/2024
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21297103/04/2024
    Labeler - Target Corporation (006961700)
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