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  5. Label Information: Childrens Allergy Relief

FDA Label for Childrens Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON

Childrens Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid 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:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011


Active Ingredient (In Each 5 Ml Teaspoonful)



Loratadine 5 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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.


Stop Use And Ask A Doctor If



  • an allergic reaction to this product occurs. Seek medical help right away.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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



adults and children 6 years and over2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
children 2 to under 6 years of age1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information



  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 77°F)

Inactive Ingredients



artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose


Principal Display Panel - 120 Ml Bottle Carton



RITE
AID®
PHARMACY

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

ORIGINAL
PRESCRIPTION
STRENGTH

children's
allergy
relief

loratadine oral solution
5 mg/5 mL antihistamine

fruit flavored oral solution

INDOOR &
OUTDOOR ALLERGIES

NON-DROWSY†

DYE FREE

24 hour relief of:

sneezing & runny nose
itchy, watery eyes
itchy throat or nose

2 years & older

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton - childrens 01

Principal Display Panel - 120 mL Bottle Carton - childrens 01


* Please review the disclaimer below.