LORATADINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Product summary:

Product: 50090-4300 NDC: 50090-4300-0 10 TABLET in a BOTTLE NDC: 50090-4300-1 20 TABLET in a BOTTLE NDC: 50090-4300-3 15 TABLET in a BOTTLE NDC: 50090-4300-4 30 TABLET in a BOTTLE NDC: 50090-4300-5 90 TABLET in a BOTTLE NDC: 50090-4300-6 7 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                LORATADINE- LORATADINE TABLET
A-S MEDICATION SOLUTIONS
----------
NORTHSTAR RXLLC LORATADINE TABLETS 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:
•
•
•
•
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. (1-
800-222-1222)
runny nose
itchy, watery eyes
sneezing
itching of the nose or throat
DIRECTIONS
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
•
•
INACTIVE INGREDIENTS
lactose monohydrate, magnesium stearate, povidone, pregelatinized
starch
QUESTIONS OR COMMENTS?
1-800-206-7821
HOW SUPPLIED
Product: 50090-4300
NDC: 50090-4300-0 10 TABLET in a BOTTLE
NDC: 50090-4300-1 20 TABLET in a BOTTLE
NDC: 50090-4300-3 15 TABLET in a BOTTLE
NDC: 50090-4300-4 30 TABLET in a BOTTLE
NDC: 50090-4300-5 90 TABLET in a BOTTLE
NDC: 50090-4300-6 7 TABLET in a BOTTLE
LORATADINE
do not use if printed foil under cap is broken or missing
store between 20 to 25 C (68 to 77 F)
°
°
°
°
LORATADINE
loratadine tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:50090-4300(NDC:16714-898)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
LORATADINE
1
                                
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