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 Camber Consumer Care Inc. 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(S)
Active ingredient (in each tablet)
Loratadine USP, 10 mg
Purpose
Antihistamine
Use(S)
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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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 Doctor If
an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy/Breastfeeding
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 tablet daily; not more than 1 tablet in 24 hours
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| children under 6 years of age
| ask a doctor
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| consumers with liver or kidney disease
| ask a doctor
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Other Information
Bottles:
- Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
- store between 20° to 25°C (68° to 77°F)
- safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn
- store between 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Blisters packs:
Inactive Ingredients
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions Or Comments?
Call 1-888-588-1418
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