LORATADINE- loratadine tablet 
A-S Medication Solutions

----------

Loratadine Tablet 10 mg

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

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

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.

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

Inactive ingredients

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

HOW SUPPLIED

Product: 50090-0838

NDC: 50090-0838-0 10 TABLET in a BOTTLE

NDC: 50090-0838-1 20 TABLET in a BOTTLE

NDC: 50090-0838-3 15 TABLET in a BOTTLE

NDC: 50090-0838-4 30 TABLET in a BOTTLE

NDC: 50090-0838-5 90 TABLET in a BOTTLE

NDC: 50090-0838-6 7 TABLET in a BOTTLE

Questions or comments?

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

Manufactured by:Manufactured for:
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

Revised: August 2018

Loratadine

Label Image
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0838(NDC:60505-0147)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code LOR;10;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-0838-590 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
2NDC:50090-0838-120 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
3NDC:50090-0838-315 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
4NDC:50090-0838-67 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
5NDC:50090-0838-010 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
6NDC:50090-0838-430 in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647101/24/2005
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0838) , REPACK(50090-0838)

Revised: 1/2020
Document Id: 9ffc1763-9de3-4300-8e9b-6314c59027dd
Set id: 04a49370-7617-4097-9921-75cbd9fc4420
Version: 12
Effective Time: 20200118
 
A-S Medication Solutions