Label: LORATADINE- loratadine solution

  • NDC Code(s): 69230-322-12, 69230-322-24
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 28, 2021

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!