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Loratadine by Rebel Distributors Corp

Medically reviewed on Feb 23, 2018

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

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.
  • 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.

Directions
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

PRINCIPAL DISPLAY PANEL - 4 FL OZ Label

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

LORATADINE 
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 
glycerin 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sucrose 
Product Characteristics
ColorYELLOW (Clear, colorless to light yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#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
ANDAANDA07680508/20/2004
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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