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  5. Label Information: Loratadine Allergy Relief

FDA Label for Loratadine Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    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?
    14. PRINCIPAL DISPLAY PANEL

Loratadine Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, 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.

Active Ingredient(S)



Loratadine, USP 10 mg


Purpose



Antihistamine


Use(S)



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

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

children under 6 years of age

ask a doctor

consumers with liver and kidney disease

ask a doctor


Other Information



  • •store between 20° to 25° C (68° to 77° F)
  • •protect from excessive moisture
  • •TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW AN SIGN OF TAMPERING.

Inactive Ingredients



Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch


Questions?



or to report an adverse event call 800-824-7984 Monday - Friday 9am - 4pm MST


Principal Display Panel



Compare to the active ingredient in CLARITIN®

When taken as directed. See Drug Facts Panel.

WinCo FOODS

24 Hour

NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS, USP10 mg/ANTIHISTAMINE

Original Prescription Strength

Relief of:

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

    • 10 Tablets

    DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

    5113359/0914

    Compare to the active ingredient in CLARITIN®

    When taken as directed. See Drug Facts Panel.

    WinCo FOODS

    24 Hour

    NON-DROWSY

    Allergy Relief

    Indoor & Outdoor Allergies

    LORATADINE TABLETS, USP10 mg/ANTIHISTAMINE

    Original Prescription Strength

    Relief of:

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

      • 30 Tablets

      DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

      5113370/0914


* Please review the disclaimer below.