FDA Label for Childrens Allergy
View Indications, Usage & Precautions
Childrens Allergy Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. 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 PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
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
- 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
- use only with enclosed dosing cup
adults and children 6 years and over | 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours |
children 2 to under 6 years of age | 1 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 disease | ask a doctor |
Other Information
- do not use if carton is opened, or if imprinted safety seal is broken or missing
- see bottom panel for expiration date
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.
Principal Display Panel - 120 Ml Bottle Carton
Publix
NDC 56062-092-08
INDOOR & OUTDOOR ALLERGIES
children's allergy
LORATADINE
ORAL SOLUTION, 5 mg/5 mL
ANTIHISTAMINE
24-hour relief of:
- sneezing, runny nose
- itchy, watery eyes
- itchy throat or nose
Ages 2 yrs. and older
DYE FREE
SUGAR-FREE
Grape-Flavored Syrup
Dosing Cup Enclosed
*Compare to Active
Ingredient in Children's Claritin®
24 Hour
Non-Drowsy†
†When taken as directed.
See Drug Facts Panel
4 FL OZ (120 mL)
* Please review the disclaimer below.