Label: LORATADINE SOFTGELS- loratadine capsule, liquid filled

  • 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(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.

    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 BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

    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.
    • side effects occur.

    If pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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

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

    PROTECT FROM FREEZING

  • Inactive ingredients

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

  • NDC 49035-686-30

    NDC 495035-686-30

  • INGREDIENTS AND APPEARANCE
    LORATADINE SOFTGELS 
    loratadine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-686
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERYL CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize3mm
    FlavorImprint Code 21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-686-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product06/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20621406/04/2018
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - TIME CAP LABS INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49035-686)
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