Loratadine
Perrigo Loratadine Tablets, 10 mg Drug Facts
c72d8a30-520e-4d25-8f02-0c891e070a1a
HUMAN OTC DRUG LABEL
Aug 20, 2025
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loratadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (4)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
Compare to Claritin® active ingredient
Original Prescription Strength
Non-Drowsy*
Loratadine Tablets, 10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
actual size
30 TABLETS
Padagis®
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Loratadine 10 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
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 right away. (1-800-222-1222)
DOSAGE & ADMINISTRATION SECTION
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 |
STORAGE AND HANDLING SECTION
Other information
•
do not use if printed foil under cap is broken or missing
•
store between 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
lactose monohydrate, magnesium stearate, povidone, pregelatinized starch
OTC - QUESTIONS SECTION
Questions or comments?
1-800-719-9260