FDA Label for Loratadine Odt

View Indications, Usage & Precautions

Loratadine Odt Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution, 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.

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



NDC 41250-527-31

Compare to Claritin®Reditabs®active ingredient**

meijer

Original Prescription Strength

Non-Drowsy*

24 HOUR RELIEF

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg · Antihistamine

For Adults and Children six years and older!

No Water Needed · Melts in Your Mouth!

Indoor & Outdoor Allergies

For 24 Hour Relief of:

sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

*When taken as directed.

See Drug Facts Panel.

30 ORALLY DISINTEGRATING TABLETS

DIST.BY MEIJER DISTRIBUTION, INC.

5078746/R0410

NDC 41250-513-24

Compare to ALAVERT®active ingredient**

meijer

Original Prescription Strength

Non-Drowsy*

24 HOUR RELIEF

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg • Antihistamine

For Adults and Children six years and older!

Mint Flavored

No Water Needed · Melts in Your Mouth!

For 24 Hour Relief of:

sneezing; runny nose;

itchy, watery eyes; itchy throat or nose

Indoor & Outdoor Allergies

24 ORALLY DISINTEGRATING TABLETS

*When taken as directed.

See Drug Facts Panel.

DIST.BY MEIJER DISTRIBUTION, INC.

5078747/R0410


* Please review the disclaimer below.