FDA Label for Dye-free Childrens Loratadine
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
- 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
- PRINCIPAL DISPLAY PANEL - 5 MG TABLET BLISTER PACK CARTON
Dye-free Childrens Loratadine 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 Chewable Tablet)
Loratadine USP, 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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor ifan 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
- chew or crush tablets completely before swallowing.
| adults and children 6 years and over | chew 2 tablets daily; not more than 2 chewable tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 chewable tablet in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- phenylketonurics: contains phenylalanine 1.25 mg per tablet.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 68° to 77°F (20° to 25°C).
Inactive Ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Principal Display Panel - 5 Mg Tablet Blister Pack Carton
NDC 56062-921-20
FOR AGES 2+ YEARS
INDOOR & OUTDOOR ALLERGIES
children'sallergy
LORATADINE CHEWABLE TABLETS USP, 5 mg
ANTIHISTAMINE
Non-drowsy*
24-hour relief of:
• Sneezing • Runny nose
• Itchy, watery eyes • Itchy throat or nose
DYE FREE
ACTUAL
SIZE
20
CHEWABLE
TABLETS
GRAPE FLAVORED
*When taken as directed. See Drug Facts Panel
†Compare to the active ingredient
of Children's Claritin
®Chewables
* Please review the disclaimer below.