Label: LORATADINE- loratadine solution

  • NDC Code(s): 69230-322-12, 69230-322-24
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 28, 2021

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  • ACTIVE INGREDIENT(S)

    (in each 5 mL teaspoonful)
    Loratadine USP, 5mg


  • PURPOSE

    Antihistamine

  • USE(S)

    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

     •use only with enclosed dosing cup


    adults and children 6 years and over
    		2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
    children 2 to under 6 years of age
    		1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor


  • OTHER INFORMATION


    • Sodium Free
    • do not use if tape imprinted with 'SEALED FORYOUR PROTECTION' on top and bottom flaps of carton is not intact
    • store between 20° to 25°C (68° to 77°F)


  • INACTIVE INGREDIENTS


    ART grape flavor, edetate disodium dihydrate, glycerin, maltitol solution, monobasic sodium phosphate, non crystallizing sorbitol solution, phosphoric acid, propylene glycol, purified water, sodium benzoate and sucralose

  • QUESTIONS OR COMMENTS?

    Call 1-888-588-1418

    Distributed by:
    Camber Consumer Care, Inc.
    Piscataway, NJ 08854, USA.


  • STORAGE

  • PRINCIPAL DISPLAY PANEL

    Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label

    loratadine-os-carton

  • INGREDIENTS AND APPEARANCE
    LORATADINE  
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-322
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SORBITOL (UNII: 506T60A25R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Coloryellow (colorless to yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-322-121 in 1 CARTON05/07/2021
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69230-322-241 in 1 CARTON05/07/2021
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21040905/07/2021
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hetero Labs Limited Unit III676162024analysis(69230-322) , manufacture(69230-322)
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