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loratadine by MARKSANS PHARMA LIMITED

Dosage form: capsule, liquid filled
Ingredients: LORATADINE 10mg
Labeler: MARKSANS PHARMA LIMITED
NDC Code: 25000-021

Loratadine

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




LORATADINE 
loratadine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-021
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
CAPRIC ACID 
POVIDONE K30 
WATER 
SORBITOL 
POLYSORBATE 80 
SORBITAN 
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeOVAL (oval shaped) Size3mm
FlavorImprint Code21
Contains    
Packaging
#Item CodePackage Description
1NDC:25000-021-08100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:25000-021-13600 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:25000-021-468 CAPSULE, LIQUID FILLED in 1 BOTTLE
4NDC:25000-021-3428 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
5NDC:25000-021-214 BAG in 1 BOX
57500 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20621410/01/2016
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIOperations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-021)

Revised: 10/2016
 
MARKSANS PHARMA LIMITED

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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