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  5. Label Information: Childrens Allergy

FDA Label for Childrens Allergy

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 5 MG TABLET BLISTER PACK CARTON

Childrens Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Target Corporation. 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.

Other



Drug Facts

Distributed by Target Corporation
Minneapolis, MN 55403


Active Ingredient (In Each Tablet)



Loratadine USP, 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

Otc - Do Not Use



Do not use if you have ever had an allergic reaction to this product or any of its ingredients.


Otc - Ask Doctor



Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


Otc - When Using



When using this product do not take more than directed. Taking more than directed may cause drowsiness.


Otc - Stop Use



Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



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 1.25 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).

Inactive Ingredients



aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid


Questions?



Call 1-800-910-6874


Principal Display Panel - 5 Mg Tablet Blister Pack Carton



NDC 11673-996-30

Compare to active ingredient in Children's Claritin® Chewables*

children's
allergy

loratadine chewable tablets USP, 5 mg
antihistamine

  •  up&up

    • non-drowsy**
    indoor and outdoor allergies
    24-hour relief of:

    • 1.sneezing
    • 2.runny nose
    • 3.itchy, watery eyes
    • 4.itchy throat or nose

      • **When taken as directed. See drug facts panel.

      GRAPE
      FLAVOR

      ACTUAL SIZE

      30
      CHEWABLE
      TABLETS

      30 CHEWABLE TABLETS

      THE CHEWABLE TABLETS ARE
      TO BE CHEWED BEFORE SWALLOWING.


* Please review the disclaimer below.