Skip to Content

← See all LORATADINE brands

LORATADINE by Rugby Laboratories

Medically reviewed on June 7, 2017

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Rugby Laboratories
NDC Code: 0536-1092

Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to thisproduct 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
adults and children 6 years and over1 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 2° and 30°C (36° and 86°F)
  • do not use if seal under bottle cap is broken or missing
  • protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions or comments? 

Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Principal Display Panel

Rugby. NDC 00536-1092-03

Non-Drowsy*

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

Sneezing Runny Nose 

Itchy, Watery Eyes 

Itchy Throat or Nose

300 mg

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint CodeLOR;10;APO
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1092-03300 TABLET in 1 BOTTLE
2NDC:0536-1092-0730 TABLET in 1 BOTTLE
3NDC:0536-1092-1190 TABLET in 1 BOTTLE
4NDC:0536-1092-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647106/22/2016
Labeler - Rugby Laboratories (079246066)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIOperations
Apotex Inc.205576023analysis(0536-1092), manufacture(0536-1092)

 
Rugby Laboratories

← See all LORATADINE brands

Further information

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

Hide