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 Mylan Institutional 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 (In Each Tablet)
Loratadine USP, 10 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
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.
Directions (24 Hour Relief)
adults and children
| 1 tablet daily; not more
|
children under 6 years of age | ask a doctor |
consumers with liver
| ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
- protect from excessive moisture
Inactive Ingredients
Corn starch, lactose monohydrate and magnesium stearate.
Questions Or Comments?
1-800-848-0462
- Serious side effects associated with use of this product may be reported to this number.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
S-11333 R2
11/16
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