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  5. Label Information: Loratadineantihistamine Antihistamine

FDA Label for Loratadineantihistamine Antihistamine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DOSAGE & ADMINISTRATION
    6. STORAGE AND HANDLING
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Loratadineantihistamine Antihistamine Product Label

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

Otc - Active Ingredient



Loratadine 10 mg

 


Otc - Purpose



Antihistamine

 


Indications & Usage



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

    •  


Warnings



if you have ever had an allergic reaction to this product or any of its ingredients

 

liver or kidney disease. Your doctor should determine if you need a different dose.

 

do not take more than directed. Taking more than directed may cause drowsiness.

 

an allergic reaction to this product occurs. Seek medical help right away.

 

ask a health professional before use.

 

In case of overdose, get medical help or contact a Poison Control Center right away.

 


Dosage & Administration



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

 


Storage And Handling



  • do not use if printed foil under cap is broken or missing
  • store at 20°-25°C (68°-77°F)

    •  


Inactive Ingredient



lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

 


Otc - Questions



1-800-719-9260

 


Package Label.Principal Display Panel Section



DRUG: Loratadineantihistamine antihistamine


GENERIC: Loratadine


DOSAGE: TABLET


ADMINSTRATION: ORAL


NDC: 49349-218-20


ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1


    • INACTIVE INGREDIENT(S):

    • LACTOSE MONOHYDRATE
    • POVIDONE
    • MAGNESIUM STEARATE
    • STARCH, CORN


      • COLOR: white


      SHAPE: OVAL


      SCORE: No score


      SIZE: 8 mm


      IMPRINT: L612


      PACKAGING: 100 in 1 VIAL



      MM1 - MM1

      MM1 - MM1


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