Label: HANDY SOLUTIONS 24 HOUR ALLERGY- loratadine tablet, film coated

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

Drug Label Information

Updated March 15, 2023

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  • Drug Facts

  • Active ingredient (in each tablet)

    Loratadine 10 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

    liver or kidney disease. Your doctor should determine if you need a different dose.

    When using this product

    do not take more than directed. Taking more than directed may cause drowsiness.

    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.

  • Directions

    Adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours

    Children under 12 years: do not give to children under 12 years of age

    Consumer with liver or kidney disease: ask a doctor before using

  • Other information

    • Tamper evident sealed packets
    • Do not use any opened or torn packets
    • Store between 68°F and 77°F (20° and 25°C)
    • Protect from excessive moisture

  • Inactive ingredients

    corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

  • Questions or comments?

    call 1-800-525-5097

  • Package Labeling:

    HS 24 hr Allergy

  • INGREDIENTS AND APPEARANCE
    HANDY SOLUTIONS 24 HOUR ALLERGY 
    loratadine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-163(NDC:47682-203)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code RX;526
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-163-011 in 1 CARTON09/22/2016
    16 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:67751-163-021 in 1 CARTON09/22/2016
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07613409/22/2016
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-163) , repack(67751-163)
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