LORATADINE - loratadine capsule, liquid filled 
MARKSANS PHARMA LIMITED

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Loratadine Liquid Filled Capsules, 10 mg (OTC)

Drug Facts

Active ingredient (in each capsule)


Loratadine  10mg



Purpose

Antihistamine

Uses

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

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 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.

Inactive ingredients

FD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution.

Questions or comments?
Call at 1-877-376-4271


Other information

Manufactured for

Time-Cap Labs. Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA



Manufactured by

Marksans Pharma Ltd.
Plot No. L-82, L-83,
Verna Indl. Estate,
Verna, GOA 403722, India.

Principal Display Panel

NDC# 25000-021-13
Loratadine Capsules, 10 mg
600 counts Bottle Label

600s-carton-label

NDC# 25000-021-34
Loratadine Capsules, 10 mg
28 counts Blister Pack

28-carton-label

PRINCIPAL DISPLAY PANEL

NDC# 25000-021-36
Loratadine Capsules, 10 mg
3x10 carton Label



3x10


LORATADINE 
loratadine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-021
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)  
CAPRIC ACID (UNII: 4G9EDB6V73)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeOVAL (oval shaped) Size3mm
FlavorImprint Code 21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-021-08100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
2NDC:25000-021-13600 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
3NDC:25000-021-468 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2016
4NDC:25000-021-3428 in 1 BLISTER PACK; Type 0: Not a Combination Product10/01/2016
5NDC:25000-021-214 in 1 BOX10/01/2016
57500 in 1 BAG; Type 0: Not a Combination Product
6NDC:25000-021-363 in 1 CARTON10/17/2020
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20621410/01/2016
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-021)

Revised: 11/2021
Document Id: adf6c78c-edb1-4ffb-a934-d8cb772e621f
Set id: c30907f9-1761-41e5-bd4e-2613e756e1c6
Version: 3
Effective Time: 20211115
 
MARKSANS PHARMA LIMITED