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Loratadine by Rebel Distributors Corp

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: Rebel Distributors Corp
NDC Code: 21695-498

Loratadine Syrup

Drug Facts

Active ingredient (in each 5 mL)

Loratadine 5 mg




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


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. You may report side effects to FDA at 1-800-FDA-1088.

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.

adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney diseaseask a doctor

Other information
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)

Inactive ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320


Oral Solution)
5 mg/5mL Antihistamine
4 FL OZ (120 mL)

loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-498(NDC:51672-2073)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
propylene glycol 
sodium benzoate 
sodium metabisulfite 
Product Characteristics
ColorYELLOW (Clear, colorless to light yellow) Score    
FlavorGRAPEImprint Code
#Item CodePackage Description
1NDC:21695-498-041 BOTTLE (BOTTLE) in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Labeler - Rebel Distributors Corp (118802834)
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 02/2011
Rebel Distributors Corp

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.