FDA Label for Loratadine
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Tenshi Kaizen Pvt Ltd. 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.
Other
Drug Facts
Manufactured by:
Tenshi Kaizen Private Limited
Bengaluru Rural – 562112, India
Revised: 11/2020
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
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Warnings
Otc - Do Not Use
Do not use if 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 have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an 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 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
- safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn
- store between 20° to 25°C (68° to 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?
1-877-244-9825
Package Label.Principal Display Panel
NDC 72983-501-01
Non-Drowsy*
Loratadine Orally Disintegrating Tablets USP, 10 mg
antihistamine
Indoor & Outdoor
Allergies
*When taken as directed. See Drug Facts Panel.
24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
No Water Needed
Melts in Your Mouth
10
ORALLY
DISINTEGRATING TABLETS
* Please review the disclaimer below.