LORATADINE capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bionpharma 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 CAPSULE, LIQUID FILLED
BIONPHARMA INC.
----------
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH CAPSULE)_
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_
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
_OTHER INFORMATION_
TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH
“SEALED FOR
YOUR PROTECTION” IS MISSING, OPEN OR BROKEN. _(FOR BOTTLE LABELS
AND_
_CARTONS)_
SAFETY SEALED: DO NOT USE IF INDIVIDUAL BLISTER UNIT PRINTED WITH
LORATADINE
CAPSULE, 10 MG IS OPEN OR TORN. _(FOR BLISTER CARTON)_
store between 20° to 25°C (68° to 77°F)
protect from freezing
_INACTIVE INGREDIENTS_
FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen,
isopropyl alcohol,
mannitol, medium chain mono- & di-glycerides, propylene glycol,
purified water, sorbitan,
sorbitol, titanium dioxide
_QUESTIONS OR COMMENTS?_
call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
This product is not manufactured or distributed by the owners of
Claritin® LIQUI-
GELS®.
Blister carton contain the following:
THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT
PACKAGE.
USE ON