Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 63941-193-04, 63941-193-06, 63941-193-09
  • Packager: Valu Merchandisers Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 11, 2020

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  • SPL UNCLASSIFIED SECTION

    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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • WARNINGS

    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 (1-800-222-1222).

  • Directions

    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • Other information

    • store between 20 to 25°C (68 to 77°F)
    • retain carton for complete product information and warnings
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

  • Questions or comments?

    1-844-705-4384

  • PRINCIPAL DISPLAY PANEL

    Best Choice®

    COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN® TABLETS†

    Non-Drowsy*

    Original Prescription Strength

    ALLERGY RELIEF 

    24 hour

    Actual Size

    Loratadine Tablets, 10 mg / ANTIHISTAMINE

    Indoor and Outdoor Allergies

    Relief of:

    • Sneezing

    • Itchy Throat or Nose

    • Itchy, Watery Eyes

    • Runny Nose

    *When taken as directed. See Drug Facts Panel

    10 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-193
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorwhite (white to off white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-193-041 in 1 CARTON07/01/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63941-193-061 in 1 CARTON07/01/2020
    230 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:63941-193-091 in 1 CARTON07/01/2020
    360 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072207/01/2020
    Labeler - Valu Merchandisers Company (868703513)
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