FDA Label for Loratadine

View Indications, Usage & Precautions

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product Good Neighbor Pharmacy. 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.

Active Ingredient (In Each Tablet)



Loratadine USP, 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

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).


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



  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.

Inactive Ingredients



Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate


Questions?



Call 1-800-406-7984


Principal Display Panel



GOOD NEIGHBOR PHARMACY®

Compare to active ingredient in Alavert***

NDC 24385-0540-53

Non-Drowsy*

Allergy Relief

loratadine orally disintegrating tablets, 10 mg

antihistamine

no water needed

melts in your mouth

Indoor & Outdoor Allergies

For Adults and Children six years and older!

For 24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching of Nose & Throat
  • 12 orally disintegrating tablets

    *When taken as directed. See Drug Facts Panel.

    Distributed By: AmerisourceBergen

    5087125/R0611

    GOOD NEIGHBOR PHARMACY®

    Compare to active ingredient in Claritin®Reditabs®**

    NDC 24385-0161-52

    Non-Drowsy*

    24 HOUR

    Allergy Relief

    loratadine orally disintegrating tablets, 10 mg

    antihistamine

    • no water needed
    • melts in your mouth
    • Indoor & Outdoor Allergies

      Relief of:

      • Sneezing
      • Runny Nose
      • Itchy, Watery Eyes
      • Itchy Throat or Nose
      • For Kids 6 yrs and older!

        10 orally disintegrating tablets

        *When taken as directed.

        See Drug Facts Panel.

        Distributed By: AmerisourceBergen

        5087123/R0611


* Please review the disclaimer below.