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 Ohm Laboratories 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 (1-800-222-1222).
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
- store between 20° and 25° C (68° and 77° F)
- protect from excessive moisture
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients
Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Questions?
Call 1-800-406-7984
Principal Display Panel
SOUND BODY™
COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®†
Relief of: Sneezing, Itchy, Watery Eyes; Runny Nose; Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
Original Prescription Strength
NON-DROWSY*
Allergy Relief
Loratadine Tablets, USP 10 mg
Antihistamine
Indoor & Outdoor Allergies
10 Tablets
24 HOURS
ALLERGY RELIEF
Manufactured by: Ohm Laboratories Inc.
5104668/R0713
* Please review the disclaimer below.