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  5. Label Information: Childrens Loratadine Oral

FDA Label for Childrens Loratadine Oral

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    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

Childrens Loratadine Oral Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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 5 Ml Teaspoonful)



Loratadine 5 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



  • •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



  • •do not use if carton is opened, or if printed neckband is broken or missing
  • •store between 20° to 25°C (68° to 77°F)

Inactive Ingredients



edetate disodium, glycerin, maltitol, monobasic sodium phosphate, natural and artificial grape flavor, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to the active ingredient in Children’s Claritin®

Children’s

Loratadine

Oral Solution,

USP, 5 mg/5 mL

(Antihistamine) ALLERGY

Non-Drowsy†

Indoor & Outdoor Allergies

SUGAR FREE

Dye Free

24 HOUR

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Ages 2 years and older

Dosing Cup Enclosed

Grape Flavor

†When taken as directed. See Drug Facts Panel.

4 FL OZ

(120 mL)


* Please review the disclaimer below.