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  5. Label Information: Claritin Reditabs

FDA Label for Claritin Reditabs

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 OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 10 TABLET CARTON
    16. PRINCIPAL DISPLAY PANEL - 60 TABLET TWIN PACK CARTON

Claritin Reditabs Product Label

The following document was submitted to the FDA by the labeler of this product Bayer Healthcare 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.

Other



Drug Facts


Active Ingredient (In Each Tablet)



Loratadine 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

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.


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



  • safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive Ingredients



anhydrous citric acid, gelatin, mannitol, mint flavor


Questions Or Comments?



1-800-CLARITIN (1-800-252-7484) or www.claritin.com


Principal Display Panel - 10 Tablet Carton



Original Prescription Strength
NDC 11523-7157-2

Non-Drowsy*
Claritin ®
RediTabs®
loratadine 10 mg/antihistamine

Indoor & Outdoor
Allergies

*When taken as directed. See Drug Facts Panel.

24
Hour

Relief of:

Principal Display Panel - 60 Tablet Twin Pack Carton



TWIN PACK

Two 30ct Cartons
60 RediTabs ®

Original Prescription Strength

NDC 11523-4329-1

Non-Drowsy*
Claritin ®
RediTabs®
loratadine 10 mg/antihistamine

Indoor & Outdoor
Allergies

*When taken as directed. See Drug Facts Panel.

24
Hour

Relief of:

* Please review the disclaimer below.