LORATADINE ALLERGY RELIEF- loratadine tablet 
Clinical Solutions Wholesale

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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

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

PRINCIPAL DISPLAY PANEL

Loratadine 10mg Packet

Package/Label Display Panel

Lorat10Lab3

Package/Label Display Panel

Lorat10Lab8

Package/Label Display Panel

Lorat10Lab9
LORATADINE ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58118-0526(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:58118-0526-990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/201306/28/2017
2NDC:58118-0526-830 in 1 BLISTER PACK; Type 0: Not a Combination Product08/16/201306/28/2017
3NDC:58118-0526-01 in 1 PACKET; Type 0: Not a Combination Product08/16/201306/28/2017
4NDC:58118-0526-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/201306/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/28/200306/28/2017
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
NameAddressID/FEIBusiness Operations
Clinical Solutions Wholesale078710347REPACK(58118-0526) , RELABEL(58118-0526)

Revised: 6/2017
Document Id: 72f05655-3a2a-4237-a95e-9f5a88a5e6d3
Set id: e1420f6f-8c08-4c4d-b44d-2d01f96ee123
Version: 2
Effective Time: 20170628
 
Clinical Solutions Wholesale