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 Kroger Company. 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.
Active Ingredient (In Each Tablet)
Loratadine USP, 5 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 beast-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 (1800-222-1222).
Directions
▪ chew or crush tablets completely before swallowing.
adults and children 6 years and over | chew 2 tablets daily; not more than 2 tablets in 24 hours |
children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 tablet in 24 hours |
children under 2 years of age | ask a doctor |
consumers with liver or kidney disease | ask a doctor |
Other Information
▪ phenylketonurics: contains phenylalanine 1.25 mg per tablet.▪ TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.▪ store between 20° to 25°C (68° to 77°F).
Inactive Ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions?
1800-632-6900
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