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  5. Label Information: Careone Childrens Allergy Relief

FDA Label for Careone Childrens Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    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. PRINCIPAL DISPLAY PANEL

Careone Childrens Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. 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 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



adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor


Other Information



  • •phenylketonurics: contains phenylalanine 1.4 mg per tablet
  • •do not use if blister unit is broken or torn
  • •store between 20° to 25°C (68° to 77°F)

Inactive Ingredients



artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid


Questions Or Comments?



1-800-719-9260


Principal Display Panel



Compare to the active ingredient in Children’s Claritin® Chewables

For Ages 2 and Older

Children’s Allergy Relief

Loratadine Chewable Tablets, 5 mg Antihistamine

Actual Size

GRAPE FLAVOR

24hr

Non-Drowsy* / 24 HOUR RELIEF OF:

Sneezing - Runny Nose - Itchy, Watery Eyes

Itchy Throat Or Nose

Indoor & Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

OUR PHARMACISTS RECOMMEND

20 CHEWABLE TABLETS


* Please review the disclaimer below.