FDA Label for Loratadine
View Indications, Usage & Precautions
Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Direct Rx. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Loratadine 10 mg
Otc - Purpose
Antihistamine
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)
Other Safety Information
•
do not use if printed foil under cap is broken or missing
•
store between 20° to 25°C (68° to 77°F)
Inactive Ingredient
lactose monohydrate, magnesium stearate, povidone, pregelatinized starch
Otc - Questions
1-800-719-9260
Dosage & Administration
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
do not use if printed foil under cap is broken or missing
store at 20°-25°C (68°-77°F)
Questions or comments?
1-800-719-9260
Indications & Usage
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
Package Label.Principal Display Panel
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