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 Spirit Pharmaceuticals Llc. 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
Loratadine 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, water eyes
- itching of the nose or throat
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 Usung 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 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
- Tamper-evident: do not use if foil under cap is missing, open or broken
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
Lactose monohydrate, magnesium stearate, povidone, starch maize pregelatinized
Questions Or Comments?
1-888-333-9792
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Compare to the active ingredient in Claritin®†
NON-DROWSY*
Original Prescription Strength
Loratadine Tablets, 10 mg / Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose
365 Tablets
*When taken as directed
See Drug Facts Panel
†This product is not manufactured or distributed by Bayer Healthcare, LLC, owner of the registered trademark Claritin®.
* Please review the disclaimer below.