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Drug Facts
Manufactured By: Tenshi Kaizen Private Limited
Bengaluru Rural - 562112, India
Loratadine Tablet, Orally Disintegrating
FDA Label NDC 72983-503
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tenshi Kaizen Pvt Ltd for the product Loratadine (NDC 72983-503). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Loratadine 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Otc - Do Not Use
Do not useif you have ever had an allergic reaction to this product or any of its ingredients
Otc - Ask Doctor
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this productdo not use more than directed. Taking more than recommended may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Place 1 tablet on tongue; tablet disentigrates with or without water.
| adults and children 6 years and over | 1 tablet daily; do not use more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers who have liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if the individual blister unit printed with Loratadine orally disintegrating tablet is open or torn
- store at 20-25°C (68-77°F)
- use tablet immediately after opening individual blister
- complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive Ingredients
anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan
Questions Or Comments?
Call Toll-free weekdays 9 AM to 5 PM EST at 1-888-375-3784
Principal Display Panel - 10 Mg Tablet Blister Pack Carton
NEW FORMULA
NON-DROWSY*
ALLERGY RELIEF
Loratadine Orally Disintegrating Tablet USP, 10 mg
Antihistamine
Indoor/Outdoor
ALLERGIES
24 Hour Relief of
Sneezing, Runny Nose
Itchy/Watery Eyes
Itchy Throat or Nose
Melts In Your Mouth
FRESH MINT Flavor
*When taken as directed. See Drug Facts Panel.
60 Orally Disintegrating Tablets
Loratadine-carton (Loratadine Carton)
* Please review the disclaimer below.
