Label: ALLERGY RELIEF- loratadine tablet

  • NDC Code(s): 61504-193-19, 61504-193-20
  • Packager: AMERIFOODS TRADING COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 2, 2023

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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 useif you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you haveliver or kidney disease.  Your doctor should determine if you need a different dose.

    When using this productdo 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

    First Street® 

    NDC 61504-193-19

    †COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®

    NON-DROWSY*

    Allergy Relief

    24 HOUR

    Loratadine Tablets

    10 mg / Antihistamine

    INDOOR & OUTDOOR ALLERGIES

    For Relief of:

    Sneezing • Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

    ACTUAL SIZE

    30 TABLETS

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61504-193
    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:61504-193-191 in 1 CARTON10/30/2023
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:61504-193-201 in 1 CARTON10/30/2023
    290 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072210/30/2023
    Labeler - AMERIFOODS TRADING COMPANY (626388680)
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