Label: ALLERGY RELIEF- loratadine capsule, liquid filled

  • NDC Code(s): 11673-986-07, 11673-986-30
  • Packager: TARGET CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 7, 2020

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  • ACTIVE INGREDIENTS

    iN EACH CAPSULE: LORATADINE 10MG

  • INACTIVE INGREDIENTS

    FD&C blue#1, gelati, mono and diglyceride of car

    FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.

  • PURPOSE

    ANTIHISTAMINE

  • WARNINGS

    DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.

    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.

  • INDICATIONS AND USAGE

    TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES:

    RUNNY NOSE

    ITCHY, WATERY EYES

    SNEEZING

    ITCHING OF THE NOSE OR THROAT

  • KEEP OUT OF REACH OF CHILDREN

    IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    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.

  • STORAGE AND HANDLING

    STORE BETWEEN 20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT)

    PROTECT FROM FREEZING

  • 10 CT BLISTER

    10 CT

  • 30 COUNT BLISTER

    30 CT

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-986
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Colorblue ((light blue)) Scoreno score
    ShapeOVALSize3mm
    FlavorImprint Code 21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-986-0710 in 1 BLISTER PACK; Type 0: Not a Combination Product04/26/2019
    2NDC:11673-986-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product04/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621404/10/2019
    Labeler - TARGET CORPORATION (006961700)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LTD925822975manufacture(11673-986)
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