Label: TOPCARE ALLERGY RELIEF- loratadine capsule, liquid filled

  • NDC Code(s): 36800-755-39, 36800-755-52
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 16, 2022

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  • Active ingredient (in each capsule)

    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 (1-800-222-1222).

  • Directions

    adults and children 6 years and over

    1 capsule daily; not more than 1 capsule in 24 hours

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor
  • Other information

    •
    do not use if blister unit is broken or torn
    •
    store between 20° to 25°C (68° to 77°F)
    •
    protect from freezing
  • Inactive ingredients

    FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    TopCare® health

    COMPARE TO CLARITIN® LIQUI-GELS® ACTIVE INGREDIENT

    NON-DROWSY*

    ORIGINAL PRESCRIPTION STRENGTH

    Allergy Relief Liquid-Gels

    LORATADINE CAPSULES, 10 mg • ANTIHISTAMINE

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    RELIEF OF:

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

    30 LIQUID-FILLED CAPSULES

    *When taken as directed.

    See Drug Facts Panel.

    actual size

    446-88-allergy-relief-liquid-gels
  • INGREDIENTS AND APPEARANCE
    TOPCARE ALLERGY RELIEF 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-755
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MANNITOL (UNII: 3OWL53L36A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUE (clear) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 446
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-755-3930 in 1 CARTON08/02/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:36800-755-5210 in 1 CARTON08/02/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20253808/02/2020
    Labeler - Topco Associates LLC (006935977)
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