LORATADINE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

Available from:

Dr. Reddy's Laboratories Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antihistamine 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LORATADINE- LORATADINE TABLET, ORALLY DISINTEGRATING
DR. REDDY'S LABORATORIES INC.
----------
LORATIDINE ORALLY DISINTEGRATING TABLETS, USP
DRUG FACTS
ACTIVE INGREDIENT (IN EACH TABLET)
Loratadine 10 mg
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 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
place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years
and over
1 tablet daily; not more than
1 tablet in 24 hours
children under 6 years of
age
ask a doctor
consumers with liver or
kidney disease
ask a doctor
OTHER INFORMATION
safety sealed: do not use if the individual blister unit imprinted
with Loratadine Orally
Disintegrating Tablet, USP is open or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
complies with USP Procedure 2 for Assay and Organic Impurities and
Test 2 for
Disintegration
INACTIVE INGREDIENTS
anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80,
pullulan
QUESTIONS OR COMMENTS?
call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784
Distributed by:
Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540
Made in India
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NON-DROWSY*
LORATADINE ORALLY DISINTEGRATING TABLETS USP, 10 MG
antihistamine
Indoor & Outdoor
ALLERGIES
*WHEN TAKEN AS DIRECTED. S