FDA Label for Childrens Non-drowsy 24-hour Allergy Relief
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON
Childrens Non-drowsy 24-hour Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Safeway 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 BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
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 bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
- see bottom panel for lot number and expiration date
- store between 20° and 25°C (68° and 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.
Questions?
Call 1-866-923-4914
Principal Display Panel - 120 Ml Bottle Carton
NDC 21130-092-08
Signature
care
Quality Guaranteed
AGES 2 YEARS AND OLDER
24 HOUR | NON-DROWSY†
Children's
Allergy
Loratadine
Oral Solution
USP, 5 mg/5 mL
Antihistamine
Allergy
GRAPE FLAVOR
Compare to Children's Claritin®
active ingredient*
- DYE FREE
- SUGAR FREE
- Indoor & outdoor allergies
- Relief of: sneezing, running nose, itchy & watery
eyes, itchy throat or nose - Dosage cup included
†When taken as directed. See Drug Facts Panel.
WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.
4 FL OZ (120 mL)
* Please review the disclaimer below.