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Loratadine by Rebel Distributors Corp

Medically reviewed on Feb 9, 2018

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

Purpose

Antihistamine

Uses

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

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 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.

Directions
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

Questions?

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 
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
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeRX;526
Contains    
Packaging
#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)
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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