FDA Label for Loratadine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG (30 TABLETS BOTTLE)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 MG CONTAINER CARTON (30 TABLETS)
Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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
Warnings
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 (1-800-222-1222) 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 seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
- store at 20° to 25°C (68° to 77°F)
- protect from excessive moisture
Inactive Ingredients
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.
Questions Or Comments?
call 1-855-274-4122
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com
Made in India
Code: TS/DRUGS/22/2009
Package Label-Principal Display Panel - 10 Mg (30 Tablets Bottle)
MAJOR®
NDC 0904-7426-46
Non-Drowsy*
Loratadine Tablets USP
10 mg
Antihistamine
24 Hour | Indoor & Outdoor Allergies
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
30 Tablets
*When taken as directed. See Drug Facts Panel.
Package Label-Principal Display Panel - 10 Mg Container Carton (30 Tablets)
MAJOR®
NDC 0904-7426-46
Compare to the
active ingredient
in Claritin®†
Non-Drowsy*
Loratadine
Tablets USP
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour
Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
30 Tablets
*When taken as directed. See Drug Facts Panel.
* Please review the disclaimer below.