LORATADINE ALLERGY RELIEF- loratadine tablet 
Lake Erie Medical DBA Quality Care Products LLC

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Drug Facts

ACTIVE INGREDIENT(S)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USE(S)

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.

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 age ask a doctor
consumers with liver and kidney disease ask a doctor

OTHER INFORMATION

  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

image description

LORATADINE ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-097(NDC:51660-526)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to Off White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55700-097-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/31/201405/31/2023
2NDC:55700-097-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/31/201405/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/28/200305/31/2023
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIBusiness Operations
Lake Erie Medical DBA Quality Care Products LLC831276758repack(55700-097)

Revised: 12/2023
Document Id: c033945f-f3eb-46f3-91c5-509106747da1
Set id: afec8e18-2c95-4a4b-a8ab-b929276612ae
Version: 6
Effective Time: 20231221
 
Lake Erie Medical DBA Quality Care Products LLC