LORATADINE capsule, liquid filled

loratadine by

Drug Labeling and Warnings

loratadine by is a Otc medication manufactured, distributed, or labeled by MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Loratadine  10mg

PURPOSE

Antihistamine

USE(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

runny nose

sneezing

itchy, water eyes

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.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

WHEN USING THIS PRODUCT

do not take more than  directed. Taking more than directed may cause drowsiness.

STOP USE AND ASK DOCTOR IF

an allergic reaction to this product occurs. Seek medical help right away

OTHER REQUIRED WARNINGS

PREGNANCY/BREASTFEEDING

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, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

STORAGE

Store at 20°-25°C (68°-77°F).

Protect from freezing.

Safely sealed: do not use if the safety seal is open or torn.

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 25000-021
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE (Light Blue)	Score	no score
Shape	OVAL (oval shaped)	Size	3mm
Flavor		Imprint Code	21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 25000-021-08	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2016
2	NDC: 25000-021-13	600 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2016
3	NDC: 25000-021-46	8 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2016
4	NDC: 25000-021-34	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	10/01/2016
5	NDC: 25000-021-21	4 in 1 BOX	10/01/2016
5		7500 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206214	10/01/2016

Labeler - MARKSANS PHARMA LIMITED (925822975)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	MANUFACTURE(25000-021)