LORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

LORATADINE

Composition:

LORATADINE 10 mg

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
MYLAN INSTITUTIONAL INC.
----------
DRUG FACTS
_Original Prescription Strength Non-Drowsy*_
INDOOR AND OUTDOOR ALLERGIES
*When taken as directed. See Drug Facts Panel.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR
SHOW ANY SIGNS OF TAMPERING.
ACTIVE INGREDIENT (IN EACH TABLET)
Loratadine USP, 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 _(24 HOUR RELIEF)_
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_
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR
SHOW ANY SIGNS OF TAMPERING.
STORE AT 20° TO 25°C (68° TO 77°F). [SEE USP CONTROLLED ROOM
TEMPERATURE.]
PROTECT FROM EXCESSIVE MOISTURE
INACTIVE INGREDIENTS
Corn starch, lactose monohydrate and magnesium stearate.
_QUESTIONS OR COMMENTS?_
1-800-848-0462
Serious side effects associated with use of this product may be
reported to this
number.
Manufactured for:
MYLAN PHARMACEUTICALS INC.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
Distributed by:
MYLAN INSTITUTIONAL INC.
Rockford, IL 61103 U.S.A.
S-11333 R2
11/16
PRINCIPAL DISPLAY PANEL – 10 MG
NDC 51079-246-20
LO