1. Home
  2. Labeler Index
  3. Glaxosmithkline Consumer Healthcare Holdings (us) Llc
  4. 0067-6122
  5. Label Information: Allergy Relief

FDA Label for Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK DOCTOR
    6. WHEN USING
    7. STOP USE
    8. PREGNANCY OR BREAST FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. OVERDOSE
    11. OTHER INFORMATION
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. QUESTIONS
    15. PRINCIPAL DISPLAY

Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) 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



loratadine 10mg


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



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


Ask Doctor



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


When Using



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


Stop Use



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


Pregnancy Or Breast Feeding



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


Keep Out Of Reach Of Children



Keep out of reach of children.


Overdose



In case of overdose, get medical help or contact a Poison Control Center right away.


Other Information



  • safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only)
  • safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only)
  • store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

Directions



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

Inactive Ingredients



lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate


Questions



call 1-800-452-0051

 

 Distributed by DOLGENCORP, LLC

100 Mission Ridge

Goodlettsville, TN 37072


Principal Display



Dollar General

* Please review the disclaimer below.