Label: CHILDRENS LORATADINE- loratadine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 23, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL (teaspoonful) (TSP))

    Loratadine 5 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.

  • Directions

    adults and children 6 years and older2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
    children 2 to under 6 years of age1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • Each teaspoonful (TSP) contains: sodium 1 mg
    • Store between 20° to 25°C (68° to 77°F)

    Children's Loratadine Oral Solution is a clear, grape flavored solution supplied in the following oral dosage form:

    NDC 0121-0849-10:10 mL unit dose cup.
    NDC 0121-0849-40:Case contains 40 unit dose cups of 10 mL (0121-0849-10) packaged in 4 trays of 10 unit dose cups each.
  • Inactive ingredients

    Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

  • Questions

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY
    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave
    Carmel, NY 10512

  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

    NDC 0121-0849-10

    Children's Loratadine
    Oral Solution

    Dye Free/ Alcohol Free/ Sugar Free

    10 mg/ 10 mL

    USUAL DOSAGE: See attached Drug Facts

    This unit-dose package is not child-resistant.

    Store at 20° to 25°C (68° to 77°F)
    [See USP Controlled Room Temperature].

    10 x 10 mL Unit-Dose Cups

    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605

    T0849100218
    R02/18

    Principal Display Panel - 10 mL Cup Tray Label
  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0849(NDC:54838-554)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0849-404 in 1 CASE05/28/2018
    110 in 1 TRAY
    1NDC:0121-0849-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07742111/24/2010
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693repack(0121-0849)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lannett Company, Inc.161630033label(0121-0849)