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Loratadine by Rebel Distributors Corp

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-499

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Loratadine Tablets

Active ingredient

Loratadine USP, 10 mg




temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing


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 thsi 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.

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

store between 20 and 25°C (68 and 77°F) · protect from excessive moisture.

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch


call 1-800-406-7984

†This product is not manufactured or distributed by Schering-Plough Healthcare Products Inc., owner of the registered trademark Claritin®.

Manufactured by
Ohm Laboratories, Inc.
North Brunswick, NJ 08902

Repackaged by
Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-499(NDC:51660-526)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
Product Characteristics
ColorWHITEScoreno score
FlavorImprint CodeRX;526
#Item CodePackage Description
1NDC:21695-499-1515 TABLET (TABLET) in 1 BOTTLE
2NDC:21695-499-2020 TABLET (TABLET) in 1 BOTTLE
3NDC:21695-499-3030 TABLET (TABLET) in 1 BOTTLE
4NDC:21695-499-9090 TABLET (TABLET) in 1 BOTTLE
5NDC:21695-499-72120 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/21/2010
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.