LORATADINE- loratadine capsule, liquid filled 
SMART SENSE (KMART)

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KMART 686T

LORATADINE 10MG

DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.

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.

ANTIHISTAMINE

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES:

RUNNY NOSE

ITCHY, WATERY EYES

SNEEZING

ITCHING OF THE NOSE OR THROAT

IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

ADULTS AND CHILDREN 6 YEARS AND OVER: 1 CAPSULE DAILY; NOT MORE THAN 1 CAPSULE IN 24 HOURS.

CHILDREN UNDER 6 YEARS OF AGE: ASK A DOCTOR.

CONSUMERS WITH LIVER OR KIDNEY DISEASE: ASK A DOCTOR.

STORE BETWEEN  20-25 DEGREES CELSIUS (67-77 DEGREES FAHRENHEIT)

PROTECT FROM FREEZING

FD&C BLUE #1, GELATIN, MONO AND DIGLYCERIDE OF CAPRYLIC/CAPRIC ACID, PHARMACEUTICAL INK, POLYSORBATE 80, POVIDONE, PURIFIED WATER, SORBITOL SORBITAN SOLUTION.

image description

LORATADINE 
loratadine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-686
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize3mm
FlavorImprint Code 21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49738-686-0710 in 1 BLISTER PACK; Type 0: Not a Combination Product01/31/2017
2NDC:49738-686-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20621401/31/2017
Labeler - SMART SENSE (KMART) (008965873)
Registrant - TIME CAP LABORATORIES INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49738-686)

Revised: 5/2018
Document Id: 6c556dbe-66fd-907c-e053-2991aa0a475d
Set id: c2db3398-ead6-4bb6-8aa6-f1366a846144
Version: 2
Effective Time: 20180516
 
SMART SENSE (KMART)