Label: LORATADINE capsule, liquid filled

  • NDC Code(s): 49738-686-07, 49738-686-30
  • Packager: SMART SENSE (KMART)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 16, 2018

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  • ACTIVE INGREDIENT

    LORATADINE 10MG

  • 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.

  • PURPOSE

    ANTIHISTAMINE

  • INDICATIONS & 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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-686
    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 (UNII: 2G86QN327L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize3mm
    FlavorImprint Code 21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49738-686-0710 in 1 BLISTER PACK; Type 0: Not a Combination Product01/31/2017
    2NDC:49738-686-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621401/31/2017
    Labeler - SMART SENSE (KMART) (008965873)
    Registrant - TIME CAP LABORATORIES INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49738-686)
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