1. Home
  2. Labeler Index
  3. Aurohealth Llc
  4. 58602-423
  5. Label Information: Loratadine

FDA Label for Loratadine

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 MG/5 ML  (60 ML BOTTLE)
    15. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 MG/5 ML CARTON (60 ML)

Loratadine Product Label

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

Drug Facts



Active ingredient (in each 5 mL teaspoonful)
Loratadine USP 5 mg


Purpose



Antihistamine


Uses



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



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 (1-800-222-1222) right away.


Directions




  • use only with enclosed dosing cup

    • adults and children 6 years and over
    		2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours 
    children 2 to under 6 years of age
    		1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor

Other Information



  • each teaspoonful contains: sodium 6 mg
  • do not use if carton is opened, or if cap safety seal is broken or missing.
  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients



artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.


Questions Or Comments?



Call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648

Made in India

 Code:TS/DRUGS/19/1993






Package Label-Principal Display Panel - 5 Mg/5 Ml  (60 Ml Bottle)



NDC 58602-423-11

Ages
2 years
and older

Loratadine
Oral Solution USP
5 mg/5 mL

Antihistamine
 Non-Drowsy*

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

    • Do not use if carton is opened,
    or if cap safety seal is broken
     or missing.

Package Label-Principal Display Panel - 5 Mg/5 Ml Carton (60 Ml)



NDC 58602-423-11

#Compare to the
 active ingredient in
children’s Claritin®


Ages  

2years
and older

Loratadine
Oral Solution USP
5 mg/5 mL

Antihistamine

Non-Drowsy*

24 Hour Relief of:


* Please review the disclaimer below.