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  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Strides Pharma 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.

Other



Drug Facts

Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Distributed by:

Strides Pharma Inc.

East Brunswick,

NJ 08816

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 over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask 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 59556-917-01

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

image - 75feb5a0 dffb 46af b735 250dd151eb77 01

image - 75feb5a0 dffb 46af b735 250dd151eb77 01


* Please review the disclaimer below.