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 Select Brand. 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 (1-800-222-1222).
Directions
- place 1 tablet on tongue; tablet disintegrates, with or without water
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
- Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture.
- keep in a dry place.
- use tablet immediately after opening individual blister.
Inactive Ingredients
Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate
Questions?
Call 1-800-406-7984
Principal Display Panel
select brand®
NDC 15127-979-10
NON-DROWSY*
Original Prescription Strength
Allergy Relief Tablets
Loratadine Orally Disintegrating Tablets, 10 mg
Antihistamine
24 Hour Allergy Relief
Indoor & Outdoor Allergies
No Water Needed
Melts in Your Mouth
Relief of: Sneezing; Runny Nose;
Itchy, Watery Eyes; Itchy Throat or Nose
For Adults & Children six years & older!
10 Orally Disintegrating Tablets
٭Compare to the active ingredient of Claritin®RediTabs®
*When taken as directed. See Drug Facts Panel.
Distributed by: SELECT BRAND®DISTRIBUTORS
5079375/R0610
* Please review the disclaimer below.