LORATADINE- loratadine capsule, liquid filled 
TIME CAP LABORATORIES INC

----------

TCL 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:49483-686
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:49483-686-0710 in 1 BLISTER PACK; Type 0: Not a Combination Product10/13/2016
2NDC:49483-686-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product10/13/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20621410/13/2016
Labeler - TIME CAP LABORATORIES INC (037052099)
Registrant - TIME CAP LABORATORIES INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-686)

Revised: 5/2018
Document Id: 6c562c37-86ca-42c2-e053-2a91aa0a8a8a
Set id: 85b26cf3-448c-4d4f-93a2-aa89530ec1f1
Version: 4
Effective Time: 20180516
 
TIME CAP LABORATORIES INC